Quick answers
- What is Clindamycin used for?
- The FDA-approved label (Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, March 10, 2026) says: “Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Clindamycin?
- The “Adverse Reactions” section of the FDA label (Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, March 10, 2026) begins: “The following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, nausea, vomiting, and diarrhea (see BOXED WARNING). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Clindamycin?
- The “Drug Interactions” section of the FDA label (Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, March 10, 2026) begins: “Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clindamycin have a boxed warning?
- Yes. The FDA label for Clindamycin Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Clindamycin?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Clindamycin been recalled?
- FDA enforcement reports list 12 recalls of products of this medicine; the newest started August 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clindamycin?
- 61 companies list prescription products of Clindamycin in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and NuCare Pharmaceuticals, Inc.
What Clindamycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. …
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (capsule, oral), Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 162 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
92 of 162 FDA labels for this medicine have a boxed warning.
Clindamycin boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile.
Read more of this section
Because clindamycin hydrochloride therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
Clindamycin side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, nausea, vomiting, and diarrhea (see BOXED WARNING). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS).
Read more of this section
Esophagitis and esophageal ulcer have been reported, particularly when taken in a lying position or with a small amount of water. An unpleasant or metallic taste has been reported after oral administration. Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (see WARNINGS). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction, cutaneous vasculitis, symmetrical drug-related intertriginous and flexural exanthema and hypersensitivity have also been reported. Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported (see Hypersensitivity Reactions). Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Renal: Acute kidney injury (see WARNINGS). Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing. Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Musculoskeletal: Cases of polyarthritis have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
Clindamycin drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin.
Read more of this section
Therefore, inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness. In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
Clindamycin dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
If significant diarrhea occurs during therapy, this antibacterial drug should be discontinued (see BOXED WARNING). Administer clindamycin hydrochloride capsules with a full glass of water (6 to 8 ounces, approximately 200 to 250 mL) and at least 30 minutes before lying down to reduce the potential for esophageal irritation (See ADVERSE REACTIONS). Adults: Serious infections – 150 to 300 mg every 6 hours. More severe infections – 300 to 450 mg every 6 hours.
Read more of this section
Pediatric Patients (who are able to swallow capsules): Serious infections – 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections – 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. Clindamycin hydrochloride capsules are not suitable for pediatric patients who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use the clindamycin palmitate oral solution in some cases. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE ® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules. In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
Clindamycin in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Teratogenic effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.
Read more of this section
Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m 2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended adult human dose based on mg/m 2, respectively) revealed no evidence of teratogenicity.
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
Clindamycin and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL. Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred.
Read more of this section
Monitor the breastfed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibacterial drug-associated colitis. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
When Clindamycin should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Clindamycin hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
Clindamycin overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.
— FDA label: Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Capsule · Injection, solution · Gel · Solution · Lotion · Aerosol, foam · Cream · Swab · Suppository · Capsule, gelatin coated |
|---|---|
| Route | Oral · Topical · Intravenous · Intramuscular · Vaginal |
| Prescription products | 203 in the FDA NDC Directory |
| Brand names | Cleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1%, Cleocin, Clindacin Etz, Clindesse, Clindamycin Phoaphate Topical Usp, 1%, Xaciato, Clindacin, Clindagel, Clindacin P, Cleocin T |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| clindamycin hydrochloride 150 mg capsule | Generic | $0.1048 per capsule |
| clindamycin hydrochloride 300 mg capsule | Generic | $0.1785 per capsule |
| clindamycin hydrochloride 75 mg capsule | Generic | $0.2692 per capsule |
| clindamycin phosphate 1 g/10 mL gel | Generic | $3.63 per mL |
| clindamycin phosphate 1% aerosol, foam | Generic | $1.78–$2.15 per gram 7 packages, lowest to highest |
| clindamycin phosphate 1% gel | Generic | $0.1362–$0.1475 per gram 20 packages, lowest to highest |
| clindamycin phosphate 1% gel | Generic | $3.63 per mL |
| clindamycin phosphate 10 mg/mL lotion | Generic | $0.2323 per mL |
| clindamycin phosphate 10 mg/mL solution | Generic | $0.2900 per unit |
| clindamycin phosphate 10 mg/mL solution | Generic | $0.1514–$0.1892 per mL 14 packages, lowest to highest |
| clindamycin phosphate 10 ug/mL lotion | Generic | $0.2323 per mL |
| clindamycin phosphate 100 mg suppository | Brand: Cleocin | $60.24 per suppository |
| clindamycin phosphate 100 mg/5 g cream | Brand: Clindesse | $26.60 per gram |
| clindamycin phosphate 100 mg/5 g gel | Brand: Xaciato | $18.89 per gram |
| clindamycin phosphate 2% cream | Generic | $1.87 per gram |
| clindamycin phosphate 2% cream | Brand: Cleocin | $1.79 per gram |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack23 products
- A-S Medication Solutions18 products
- NuCare Pharmaceuticals, Inc.13 products
- Pharmacia & Upjohn Company LLC12 products
- Medical Purchasing Solutions, LLC8 products
- Baxter Healthcare Company8 products
- Padagis Israel Pharmaceuticals Ltd6 products
- Sun Pharmaceutical Industries, Inc.6 products
- Glenmark Pharmaceuticals Inc., USA5 products
- Proficient Rx LP5 products
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC4 products
- Chartwell RX, LLC4 products
- Preferred Pharmaceuticals Inc.4 products
- Remedyrepack Inc.4 products
- Asclemed USA, Inc.4 products
- Encube Ethicals, Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Aurobindo Pharma Limited3 products
- NorthStar Rx LLC3 products
- Northwind Health Company, LLC3 products
- St. Mary's Medical Park Pharmacy3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Micro Labs Limited3 products
- Hikma Pharmaceuticals USA Inc.3 products
- Sandoz Inc3 products
- Solaris Pharma Corporation2 products
- Eurofarma, Inc.2 products
- Zydus Lifesciences Limited2 products
- Viona Pharmaceuticals Inc2 products
- Baxter Healthcare Corporation2 products
- Henry Schein, Inc.2 products
- Amneal Pharmaceuticals NY LLC2 products
- Hawaii Repack, Inc.2 products
- American Health Packaging2 products
- Advanced Rx of Tennessee, LLC2 products
- Major Pharmaceuticals2 products
- Redpharm Drug2 products
- Civica, Inc.2 products
- Sagent Pharmaceuticals1 product
- Carnegie Pharmaceuticals LLC1 product
- Oceanside Pharmaceuticals1 product
- Rising Pharma Holdings, Inc.1 product
- Alembic Pharmaceuticals Inc.1 product
- i3 Pharmaceuticals, LLC1 product
- Organon LLC1 product
- Medimetriks Pharmaceuticals, Inc.1 product
- ProPharma Distribution1 product
- Bausch Health US, LLC1 product
- Alembic Pharmaceuticals Limited1 product
- Brisk Pharmaceuticals1 product
- Unit Dose Solutions, Inc.1 product
- Cardinal Health 107, LLC1 product
- Quality Care Products, LLC1 product
- Sportpharm LLC1 product
- RedPharm Drug, Inc.1 product
- Verityrx, LLC1 product
- AvPAK1 product
- Coupler LLC1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Direct_Rx1 product
- Golden State Medical Supply, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050162 CLEOCIN HYDROCHLORIDE | Pfizer | February 22, 1970 | 90, latest September 1, 2026 2026: Labeling · 2026: Labeling · 2026: Labeling |
| NDA050441 CLEOCIN PHOSPHATE | Pfizer | October 2, 1972 | 35, latest March 26, 2026 2026: Labeling · 2026: Labeling · 2022: Labeling |
| NDA050600 CLEOCIN T | Pfizer | May 31, 1989 | 12, latest November 12, 2025 2025: Labeling · 2019: Labeling · 2019: Labeling |
| NDA050615 CLEOCIN T | Pfizer | January 7, 1987 | 10, latest November 12, 2025 2025: Labeling · 2019: Labeling · 2019: Labeling |
| NDA050680 CLEOCIN | Pfizer | August 11, 1992 | 11, latest May 17, 2022 2022: Labeling · 2020: Labeling · 2019: Labeling |
| NDA050767 CLEOCIN | Pfizer | August 13, 1999 | 10, latest July 26, 2022 2022: Labeling · 2022: Labeling · 2020: Labeling |
| NDA050782 CLINDAGEL | Bausch | November 27, 2000 | — |
| NDA050793 CLINDESSE | Padagis Us | November 30, 2004 | 10, latest January 30, 2025 2025: Labeling · 2023: Labeling · 2017: Manufacturing (CMC) |
| NDA208083 CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | Baxter Hlthcare Corp | April 20, 2017 | 6, latest September 1, 2022 2022: Labeling · 2022: Labeling · 2022: Labeling |
| NDA215650 XACIATO | Organon LLC | December 7, 2021 | 1, latest March 6, 2023 2023: Labeling |
Generic approvals (40)
- ANDA064050Padagis Us · November 30, 1995
- ANDA064159Fougera Pharms Inc · June 5, 1997
- ANDA064160Fougera Pharms · January 28, 2000
- ANDA065049Padagis Us · May 25, 2000
- ANDA065061Sun Pharm Inds Ltd · February 2, 2001
- ANDA065067Fougera Pharms · January 31, 2002
- ANDA065194Epic Pharma LLC · March 22, 2004
- ANDA065184Taro Pharm Inds · March 31, 2004
- ANDA065139Fougera Pharms · December 27, 2004
- ANDA065243Chartwell Molecular · August 12, 2005
- ANDA065442Aurobindo Pharma · August 26, 2009
- ANDA090785Padagis Israel · March 31, 2010
- ANDA065513Epic Pharma LLC · June 17, 2010
- ANDA090108Sagent Pharms Inc · September 30, 2011
- ANDA090109Sagent Pharms Inc · September 30, 2011
- ANDA201692Sandoz Inc · May 31, 2012
- ANDA208084Baxter Hlthcare Corp · June 28, 2017
- ANDA209846Chartwell Rx · February 8, 2018
- ANDA208767Zydus Lifesciences · July 16, 2018
- ANDA207402Micro Labs · November 5, 2018
- ANDA209914Encube Ethicals · January 28, 2019
- ANDA210004Taro · March 11, 2020
- ANDA211872Amvika · July 29, 2020
- ANDA214052Sun Pharma Canada · November 10, 2020
- ANDA212104Padagis Israel · December 31, 2020
- ANDA214251Glenmark Pharms Ltd · February 10, 2021
- ANDA214604Padagis Israel · March 8, 2021
- ANDA212438Encube · March 11, 2021
- ANDA214526Sun Pharma Canada · June 28, 2021
- ANDA212842Solaris Pharma Corp · August 13, 2021
- ANDA210778Glenmark Pharms Ltd · September 20, 2021
- ANDA215607Encube · January 18, 2022
- ANDA214668Amneal · August 5, 2022
- ANDA216957Glenmark Pharms Ltd · March 10, 2023
- ANDA214401Hikma · April 5, 2023
- ANDA216587Zydus Lifesciences · September 19, 2023
- ANDA212466Alembic · April 2, 2024
- ANDA219612Carnegie · June 13, 2025
- ANDA218942Aurobindo Pharma Ltd · March 18, 2026
- ANDA218300Rising · March 23, 2026
Shortage status
Current shortage · updated October 21, 2026 · first posted March 21, 2023
| Product | Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 6 mg/1 mL (NDC 0781-3288-09) |
|---|---|
| Availability | Available |
| Company | Sandoz Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 6, 2026 · Class II · Ongoing · D-0815-2026
CGMP Deviations
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50. — Baxter Healthcare Corporation
-
August 6, 2026 · Class II · Ongoing · D-0816-2026
CGMP Deviations
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-95 — Baxter Healthcare Corporation
-
August 6, 2026 · Class II · Ongoing · D-0808-2026
CGMP Deviations
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50. — Baxter Healthcare Corporation
-
August 6, 2026 · Class II · Ongoing · D-0817-2026
CGMP Deviations
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4 — Baxter Healthcare Corporation
-
August 6, 2026 · Class II · Ongoing · D-0818-2026
CGMP Deviations
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066- — Baxter Healthcare Corporation
-
November 26, 2025 · Class III · Ongoing · D-0257-2026
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 1 — SUN PHARMACEUTICAL INDUSTRIES INC
-
March 13, 2025 · Class II · Ongoing · D-0344-2025
CGMP Deviations
Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, — Glenmark Pharmaceuticals Inc., USA
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March 15, 2021 · Class II · Terminated · D-0568-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304- — Cardinal Health Inc.
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March 15, 2019 · Class III · Terminated · D-1067-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02 — Pfizer Inc.
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March 15, 2019 · Class III · Terminated · D-1069-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01 — Pfizer Inc.
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March 15, 2019 · Class III · Terminated · D-1068-2019
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01 — Pfizer Inc.
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June 4, 2013 · Class II · Terminated · D-609-2013
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, — Pharmacia & Upjohn LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 197518, 197519, 205964, 259233, 284215, 309329, 309332, 309333, 309335, 309336 … (+10) |
|---|---|
| SPL set ID of the quoted label | 8e66de7a-d9d4-4562-bc99-80489d482da4 |
| FDA labels (SPL) | 162 |
| FDA applications | NDA050162, NDA050441, NDA050600, NDA050615, NDA050680, NDA050767, NDA050782, NDA050793, NDA208083, NDA215650, 40 ANDA |
| Active ingredients (FDA) | CLINDAMYCIN |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Cleocin PhosphateBrand page: products, maker and price
- Clindamycin in 5 Percent DextroseBrand page: products, maker and price
- Cleocin HydrochlorideBrand page: products, maker and price
- CleocinBrand page: products, maker and price
- SepsisCondition named on the label: hospitals that treat it
- Bryant Ranch PrepackMaker or distributor
- A-S Medication SolutionsMaker or distributor
- NuCare Pharmaceuticals, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Clindamycin Hydrochloride, Glenmark Pharmaceuticals Inc., USA, effective March 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →