Quick answers
- What is Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) used for?
- The FDA-approved label (Amoxicillin and Clavulanate Potassium, Sandoz Inc, May 1, 2025) says: “Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis. …” 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 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2)?
- The “Adverse Reactions” section of the FDA label (Amoxicillin and Clavulanate Potassium, Sandoz Inc, May 1, 2025) begins: “The following are discussed in more detail in other sections of the labeling: • Anaphylactic reactions [see Warnings and Precautions (5.1)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] • Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3)] • Hepatic Dysfunction [see Warnings and Precautions (5.4)] • Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.5)] The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).” … 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 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2)?
- The “Drug Interactions” section of the FDA label (Amoxicillin and Clavulanate Potassium, Sandoz Inc, May 1, 2025) begins: “• Co-administration with probenecid is not recommended. (7.1) • Concomitant use of amoxicillin and clavulanate potassium and oral anticoagulants may increase the prolongation of prothrombin time. (7.2) • Co-administration with allopurinol increases the risk of rash. (7.3) • Amoxicillin and clavulanate potassium may reduce efficacy of oral contraceptives.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) have a boxed warning?
- The label we quote has no boxed warning, but 1 of 145 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started February 7, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2)?
- 30 companies list prescription products of Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Proficient Rx LP and A-S Medication Solutions.
What Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis. …
— FDA label: Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Amoxicillin and Clavulanate Potassium, Sandoz Inc; it covers 5 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 145 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.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 145 FDA labels for this medicine have a boxed warning.
Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) 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 are discussed in more detail in other sections of the labeling:
- Anaphylactic reactions [see Warnings and Precautions (5.1)]
- Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)]
- Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3)]
- Hepatic Dysfunction [see Warnings and Precautions (5.4)]
- Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.5)] The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%).
Read more of this section
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (less than 1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes [see Clinical Studies (14.2)]. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of amoxicillin and clavulanate potassium. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin and clavulanate potassium. Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), black hairy tongue, and hemorrhagic/pseudomembranous colitis. Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1)]. Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis.
— FDA label: Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025. This is part of the section. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) 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.
- Co-administration with probenecid is not recommended. (7.1)
- Concomitant use of amoxicillin and clavulanate potassium and oral anticoagulants may increase the prolongation of prothrombin time. (7.2)
- Co-administration with allopurinol increases the risk of rash. (7.3)
- Amoxicillin and clavulanate potassium may reduce efficacy of oral contraceptives.
Read more of this section
(7.4) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with amoxicillin and clavulanate potassium may result in increased and prolonged blood concentrations of amoxicillin. Co-administration of probenecid is not recommended. 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with amoxicillin and clavulanate potassium. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. 7.4 Oral Contraceptives Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin and clavulanate potassium, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
— FDA label: Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) 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.
- Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on amoxicillin component. (2.2, 2.3)
- Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. (2.3)
- Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component.
Read more of this section
Use of the 125 mg/5 mL oral suspension is recommended. (2.3) 2.1 Important Administration Instructions Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal. 2.2 Adult Patients See dosing regimens of amoxicillin and clavulanate potassium (based on the amoxicillin component) provided in Table 1 below. Table 1: Dosing Regimens of Amoxicillin and Clavulanate Potassium in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM Severe infections and infections of the respiratory tract one 875 mg tablet* of amoxicillin and clavulanate potassium every 12 hours or one 500 mg tablet †, ‡ of amoxicillin and clavulanate potassium every 8 hours Less severe infections one 500 mg tablet †, ‡ of amoxicillin and clavulanate potassium every 12 hours or one 250 mg tablet § of amoxicillin and clavulanate potassium every 8 hours * Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension or the amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. † Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. ‡ Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg amoxicillin and clavulanate potassium tablet [see Dosage and Administration (2.6)]. § amoxicillin and clavulanate potassium 250 mg/125 mg tablet is NOT substitutable with amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet [see Dosage and Administration (2.6)]. 2.3 Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows: Neonates and Infants Aged less than 12 weeks (less than 3 months): See dosing regimens of amoxicillin and clavulanate potassium provided in Table 2 below.
Table from the label
| TYPE OF INFECTION | DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM |
|---|---|
| Severe infections and infections of the respiratory tract | one 875 mg tablet* of amoxicillin and clavulanate potassium every 12 hoursorone 500 mg tablet†, ‡ of amoxicillin and clavulanate potassium every 8 hours |
| Less severe infections | one 500 mg tablet†, ‡ of amoxicillin and clavulanate potassium every 12 hoursorone 250 mg tablet§ of amoxicillin and clavulanate potassium every 8 hours |
— FDA label: Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025. This is part of the section. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) 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 Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours).
Read more of this section
For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
— FDA label: Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Amoxicillin has been shown to be excreted in human milk. Amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman.
— FDA label: Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025. Read the full label on DailyMed →
When Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
- History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium or to other beta-lactams (e.g., penicillins or cephalosporins). (4.1)
- History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium.
Read more of this section
(4.2) 4.1 Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium.
— FDA label: Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025. Read the full label on DailyMed →
Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) (2) 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).
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms 1. Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium.
Read more of this section
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin and clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [see Dosage and Administration (2.4)].
— FDA label: Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, film coated · Powder, for suspension · Tablet · Suspension · For suspension · Tablet, coated · Tablet, chewable |
|---|---|
| Route | Oral |
| Prescription products | 196 in the FDA NDC Directory |
| Brand names | Augmentin Es-600, Augmentin |
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 |
|---|---|---|
| amoxicillin 200 mg/5 mL · clavulanate potassium 28.5 mg/5 mL powder, for suspension | Generic | $0.0467–$0.0686 per mL 10 packages, lowest to highest |
| amoxicillin 250 mg · clavulanate potassium 125 mg tablet, film coated | Generic | $1.52 per tablet |
| amoxicillin 250 mg/5 mL · clavulanate potassium 62.5 mg/5 mL for suspension | Generic | $0.3968–$0.4543 per mL 3 packages, lowest to highest |
| amoxicillin 250 mg/5 mL · clavulanate potassium 62.5 mg/5 mL powder, for suspension | Generic | $0.3968–$0.4543 per mL 6 packages, lowest to highest |
| amoxicillin 250 mg/5 mL · clavulanate potassium 62.5 mg/5 mL suspension | Generic | $0.3968–$0.4543 per mL 3 packages, lowest to highest |
| amoxicillin 400 mg/5 mL · clavulanate potassium 57 mg/5 mL powder, for suspension | Generic | $0.0556–$0.0789 per mL 13 packages, lowest to highest |
| amoxicillin 500 mg · clavulanate potassium 125 mg tablet, film coated | Generic | $0.2490 per tablet |
| amoxicillin 600 mg/5 mL · clavulanate potassium 42.9 mg/5 mL for suspension | Generic | $0.0710–$0.0900 per mL 3 packages, lowest to highest |
| amoxicillin 600 mg/5 mL · clavulanate potassium 42.9 mg/5 mL powder, for suspension | Generic | $0.0710–$0.0900 per mL 12 packages, lowest to highest |
| amoxicillin 600 mg/5 mL · clavulanate potassium 42.9 mg/5 mL suspension | Generic | $0.0710–$0.0900 per mL 6 packages, lowest to highest |
| amoxicillin 875 mg · clavulanate potassium 125 mg tablet | Generic | $0.2818 per tablet |
| amoxicillin 875 mg · clavulanate potassium 125 mg tablet, coated | Generic | $0.2818 per tablet |
| amoxicillin 875 mg · clavulanate potassium 125 mg tablet, film coated | Generic | $0.2818 per tablet |
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.
- NuCare Pharmaceuticals, Inc.29 products
- Proficient Rx LP19 products
- A-S Medication Solutions16 products
- Bryant Ranch Prepack14 products
- PD-Rx Pharmaceuticals, Inc.12 products
- Preferred Pharmaceuticals Inc.12 products
- Remedyrepack Inc.10 products
- Asclemed USA, Inc.9 products
- Aurobindo Pharma Limited8 products
- Sportpharm LLC7 products
- Chartwell RX, LLC7 products
- Sandoz Inc6 products
- NorthStar Rx LLC6 products
- Teva Pharmaceuticals USA, Inc.5 products
- Devatis, Inc.5 products
- USAntibiotics, LLC5 products
- American Health Packaging3 products
- Micro Labs Limited3 products
- Coupler LLC2 products
- Redpharm Drug2 products
- Northwind Health Company, LLC2 products
- Hawaii Repack, Inc.2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Direct_Rx2 products
- Medsource Pharmaceuticals2 products
- DirectRx1 product
- Cipla USA Inc.1 product
- NuCare Pharmaceutials, Inc.1 product
- Allegis Holdings LLC1 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 |
|---|---|---|---|
| NDA050575 AUGMENTIN '125', AUGMENTIN '250' | Us Antibiotics | August 6, 1984 | 31, latest July 17, 2026 2026: Labeling · 2024: Labeling · 2022: Labeling |
| NDA050720 AUGMENTIN '875' | Us Antibiotics | February 13, 1996 | 29, latest July 17, 2026 2026: Labeling · 2024: Labeling · 2022: Labeling |
| NDA050725 AUGMENTIN '200', AUGMENTIN '400' | Us Antibiotics | May 31, 1996 | 32, latest July 17, 2026 2026: Labeling · 2024: Labeling · 2022: Labeling |
| NDA050755 AUGMENTIN ES-600 | Us Antibiotics | June 22, 2001 | 19, latest July 17, 2026 2026: Labeling · 2024: Labeling · 2024: Labeling |
Generic approvals (26)
- ANDA065063Sandoz · March 14, 2002
- ANDA065064Sandoz · March 15, 2002
- ANDA065066Sandoz · June 5, 2002
- ANDA065096Chartwell Rx · October 29, 2002
- ANDA065101Chartwell Rx · October 30, 2002
- ANDA065098Sandoz Inc · December 16, 2002
- ANDA065162Chartwell Rx · March 12, 2004
- ANDA065089Chartwell Rx · May 25, 2004
- ANDA065205Chartwell Rx · February 9, 2005
- ANDA065189Sandoz · August 23, 2005
- ANDA065358Sandoz Inc · August 13, 2007
- ANDA065373Hikma Pharms · November 9, 2007
- ANDA065431Cipla · November 25, 2008
- ANDA201090Aurobindo Pharma Ltd · December 20, 2011
- ANDA201091Aurobindo Pharma Ltd · December 20, 2011
- ANDA091568Aurobindo Pharma Ltd · January 20, 2012
- ANDA091569Aurobindo Pharma Ltd · January 20, 2012
- ANDA203824Hikma Pharms · August 23, 2016
- ANDA204755Micro Labs Ltd India · December 30, 2016
- ANDA205707Micro Labs Ltd India · December 30, 2016
- ANDA209371Aurobindo Pharma · April 19, 2019
- ANDA209351Deva Holding As · September 13, 2023
- ANDA209991Regcon Holdings · September 15, 2023
- ANDA209992Regcon Holdings · September 15, 2023
- ANDA210374Deva Holding As · November 29, 2023
- ANDA210416Deva Holding As · December 11, 2023
Shortage status
The FDA drug shortage list does not show these products.
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.
-
February 7, 2020 · Class II · Terminated · D-0852-2020
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20 — AuroMedics Pharma LLC
-
April 26, 2017 · Class III · Terminated · D-0868-2017
Subpotent Drug; Clavulanic Acid
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20 — Sandoz Inc
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
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
- Amoxicillin/Clav PotBrand page: products, maker and price
- Amoxicillin/Clav Pot Oral SuspBrand page: products, maker and price
- AugmentinBrand page: products, maker and price
- Augmentin Es-600Brand page: products, maker and price
- NuCare Pharmaceuticals, Inc.Maker or distributor
- Proficient Rx LPMaker or distributor
- A-S Medication SolutionsMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amoxicillin and Clavulanate Potassium, Sandoz Inc, effective May 1, 2025; 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 →