Quick answers
- What is Sulfamethoxazole and trimethoprim used for?
- The FDA-approved label (Bactrim, Sun Pharmaceutical Industries, Inc, December 30, 2024) says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of BACTRIM (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, BACTRIM (sulfamethoxazole and trimethoprim) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …” 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 Sulfamethoxazole and trimethoprim?
- The “Adverse Reactions” section of the FDA label (Bactrim, Sun Pharmaceutical Industries, Inc, December 30, 2024) begins: “The following adverse reactions associated with the use of BACTRIM or sulfamethoxazole and trimethoprim were identified in clinical trials, postmarketing or published reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.” … 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 Sulfamethoxazole and trimethoprim?
- The “Drug Interactions” section of the FDA label (Bactrim, Sun Pharmaceutical Industries, Inc, December 30, 2024) begins: “Potential for BACTRIM to Affect Other Drugs Trimethoprim is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole is an inhibitor of CYP2C9. Avoid coadministration of BACTRIM with drugs that are substrates of CYP2C8 and 2C9 or OCT2.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sulfamethoxazole and trimethoprim have a boxed warning?
- No. None of the 86 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sulfamethoxazole and trimethoprim?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sulfamethoxazole and trimethoprim been recalled?
- FDA enforcement reports list 10 recalls of products of this medicine; the newest started September 2, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Sulfamethoxazole and trimethoprim?
- 45 companies list prescription products of Sulfamethoxazole and trimethoprim in the FDA NDC Directory, including A-S Medication Solutions, Teva Parenteral Medicines, Inc. and NuCare Pharmaceuticals, Inc.
What Sulfamethoxazole and trimethoprim is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of BACTRIM (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, BACTRIM (sulfamethoxazole and trimethoprim) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …
— FDA label: Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Bactrim, Sun Pharmaceutical Industries, Inc; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 86 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.
The label quoted above has no boxed warning.
0 of 86 FDA labels for this medicine have a boxed warning.
Sulfamethoxazole and trimethoprim 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 adverse reactions associated with the use of BACTRIM or sulfamethoxazole and trimethoprim were identified in clinical trials, postmarketing or published reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read more of this section
The most common adverse reactions are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). Fatalities and serious adverse reactions, including severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including BACTRIM(see WARNINGS). Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura. Allergic/ Immune Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria, rash, periarteritis nodosa, hemophagocytic lymphohistiocytosis (HLH), systemic lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized erythematous pustulosis (AGEP), and acute febrile neutrophilic dermatosis (AFND) (see WARNINGS). Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia. Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, renal insufficiency, oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine. Metabolic and Nutritional: Hyperkalemia, hyponatremia (see PRECAUTIONS: Electrolyte Abnormalities), metabolic acidosis. Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache. Psychiatric: Hallucinations, depression, apathy, nervousness. Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred. Musculoskeletal: Arthralgia, myalgia, rhabdomyolysis.
— FDA label: Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024. This is part of the section. Read the full label on DailyMed →
Sulfamethoxazole and trimethoprim 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.
Potential for BACTRIM to Affect Other Drugs Trimethoprim is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole is an inhibitor of CYP2C9. Avoid coadministration of BACTRIM with drugs that are substrates of CYP2C8 and 2C9 or OCT2.
Read more of this section
Table 1: Drug Interactions with BACTRIM Drug(s) Recommendation Comments Diuretics Avoid concurrent use In elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported. Warfarin Monitor prothrombin time and INR It has been reported that BACTRIM may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin (a CYP2C9 substrate). This interaction should be kept in mind when BACTRIM is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed. Phenytoin Monitor serum phenytoin levels BACTRIM may inhibit the hepatic metabolism of phenytoin (a CYP2C9 substrate). BACTRIM, given at a common clinical dosage, increased the phenytoin half-life by 39% and decreased the phenytoin metabolic clearance rate by 27%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect. Methotrexate Avoid concurrent use Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations. Cyclosporine Avoid concurrent use There have been reports of marked but reversible nephrotoxicity with coadministration of BACTRIM and cyclosporine in renal transplant recipients. Digoxin Monitor serum digoxin levels Increased digoxin blood levels can occur with concomitant BACTRIM therapy, especially in elderly patients. Indomethacin Avoid concurrent use Increased sulfamethoxazole blood levels may occur in patients who are also receiving indomethacin. Pyrimethamine Avoid concurrent use Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if BACTRIM is prescribed. Tricyclic Antidepressants (TCAs) Monitor therapeutic response and adjust dose of TCA accordingly The efficacy of tricyclic antidepressants can decrease when coadministered with BACTRIM. Oral Hypoglycemics Monitor blood glucose more frequently Like other sulfonamide-containing drugs, BACTRIM potentiates the effect of oral hypoglycemic that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted. Amantadine Avoid concurrent use In the literature, a single case of toxic delirium has been reported after concomitant intake of BACTRIM and amantadine (an OCT2 substrate). Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported.
— FDA label: Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024. This is part of the section. Read the full label on DailyMed →
Sulfamethoxazole and trimethoprim 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.
BACTRIM is contraindicated in pediatric patients less than 2 months of age. Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children Adults: The usual adult dosage in the treatment of urinary tract infections is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
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Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage: Children 2 months of age or older: Weight Dose–every 12 hours lb kg Tablets 22 10 – 44 20 1 66 30 1½ 88 40 2 or 1 DS tablet For Patients with Impaired Renal Function When renal function is impaired, a reduced dosage should be employed using the following table: Creatinine Clearance (mL/min) Recommended Dosage Regimen Above 30 Usual standard regimen 15–30 ½ the usual regimen Below 15 Use not recommended Acute Exacerbations of Chronic Bronchitis in Adults The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 14 days. Pneumocystis jirovecii Pneumonia Treatment Adults and Children: The recommended dosage for treatment of patients with documented Pneumocystis jirovecii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days. 12 The following table is a guideline for the upper limit of this dosage: Weight Dose–every 6 hours lb kg Tablets 18 8 – 35 16 1 53 24 1½ 70 32 2 or 1 DS tablet 88 40 2½ 106 48 3 or 1½ DS tablets 141 64 4 or 2 DS tablets 176 80 5 or 2½ DS tablets For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table. Prophylaxis Adults: The recommended dosage for prophylaxis in adults is 1 BACTRIM DS (double strength) tablet daily. 13 Children: For children, the recommended dose is 750 mg/m 2 /day sulfamethoxazole with 150 mg/m 2 /day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim. 14 The following table is a guideline for the attainment of this dosage in children: Body Surface Area Dose–every 12 hours (m 2) Tablets 0.26 – 0.53 ½ 1.06 1 Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea, the usual adult dosage is 1 BACTRIM DS (double strength) tablet or 2 BACTRIM tablets every 12 hours for 5 days.
Table from the label
| Creatinine Clearance (mL/min) | Recommended Dosage Regimen |
|---|---|
| Above 30 | Usual standard regimen |
| 15–30 | ½ the usual regimen |
| Below 15 | Use not recommended |
— FDA label: Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024. This is part of the section. Read the full label on DailyMed →
Sulfamethoxazole and trimethoprim 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.
While there are no large, well-controlled studies on the use of sulfamethoxazole and trimethoprim in pregnant women, Brumfitt and Pursell, 11 in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or sulfamethoxazole and trimethoprim. The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving sulfamethoxazole and trimethoprim.
Read more of this section
There were no abnormalities in the 10 children whose mothers received the drug during the first trimester. In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received oral sulfamethoxazole and trimethoprim at the time of conception or shortly thereafter. Because sulfamethoxazole and trimethoprim may interfere with folic acid metabolism, BACTRIM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
— FDA label: Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024. Read the full label on DailyMed →
Sulfamethoxazole and trimethoprim and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Levels of sulfamethoxazole and trimethoprim in breast milk are approximately 2–5% of the recommended daily dose for infants over 2 months of age. Caution should be exercised when BACTRIM is administered to a nursing woman, especially when breastfeeding jaundiced, ill, stressed, or premature infants because of the potential risk of bilirubin displacement and kernicterus.
— FDA label: Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024. Read the full label on DailyMed →
When Sulfamethoxazole and trimethoprim should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
BACTRIM is contraindicated in the following situations: a known hypersensitivity to trimethoprim or sulfonamides history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides documented megaloblastic anemia due to folate deficiency pediatric patients less than 2 months of age marked hepatic damage severe renal insufficiency when renal function status cannot be monitored concomitant administration with dofetilide (see PRECAUTIONS).
— FDA label: Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024. Read the full label on DailyMed →
Sulfamethoxazole and trimethoprim 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).
Acute The amount of a single dose of BACTRIM that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundice are potential late manifestations of overdosage.
Read more of this section
Signs of acute overdosage with trimethoprim include nausea, vomiting, dizziness, headache, mental depression, confusion and bone marrow depression. General principles of treatment include the institution of gastric lavage or emesis, forcing oral fluids, and the administration of intravenous fluids if urine output is low and renal function is normal. Acidification of the urine will increase renal elimination of trimethoprim. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications. Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating sulfamethoxazole and trimethoprim. Chronic Use of BACTRIM at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. If signs of bone marrow depression occur, the patient should be given leucovorin 5 to 15 mg daily until normal hematopoiesis is restored.
— FDA label: Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet · Suspension · Injection, solution, concentrate |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 102 in the FDA NDC Directory |
| Brand names | Sulfamethoxazole and Trimethoprim Ds, Sulfatrim, Bactrim Ds, Bactrim, Sulfamethox-Tmp Ds |
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 |
|---|---|---|
| sulfamethoxazole 200 mg/5 mL · trimethoprim 40 mg/5 mL suspension | Generic | $0.0553 per mL |
| sulfamethoxazole 400 mg · trimethoprim 80 mg tablet | Generic | $0.0417 per tablet |
| sulfamethoxazole 800 mg · trimethoprim 160 mg tablet | Generic | $0.0453 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.
- A-S Medication Solutions19 products
- Teva Parenteral Medicines, Inc.6 products
- NuCare Pharmaceuticals, Inc.5 products
- Remedyrepack Inc.4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Chartwell RX, LLC4 products
- Proficient Rx LP4 products
- Northwind Health Company, LLC3 products
- Advanced Rx Pharmacy of Tennessee, LLC3 products
- Aurobindo Pharma Limited3 products
- Preferred Pharmaceuticals Inc.3 products
- Somerset Therapeutics, LLC3 products
- AvKARE2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Cronus Pharma LLC2 products
- Cardinal Health 107, LLC2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Rising Pharma Holdings, Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Bryant Ranch Prepack2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- American Health Packaging2 products
- Vista Pharmaceuticals, Inc.2 products
- Coupler LLC1 product
- AvPAK1 product
- Redpharm Drug1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Golden State Medical Supply, Inc.1 product
- Direct_Rx1 product
- Asclemed USA, Inc.1 product
- Sportpharm LLC1 product
- Unit Dose Solutions, Inc.1 product
- QPharma, Inc.1 product
- Major Pharmaceuticals1 product
- Prasco Laboratories1 product
- Atlantic Biologicals Corp.1 product
- St. Mary's Medical Park Pharmacy1 product
- ANI Pharmaceuticals, Inc.1 product
- Kesin Pharma1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- PharmPak, Inc.1 product
- Pharmasource Meds, LLC1 product
- Verityrx, LLC1 product
- Quality Care Products, LLC1 product
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals1 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 |
|---|---|---|---|
| NDA017377 BACTRIM, BACTRIM DS | Sun Pharm Industries | July 30, 1973 | 61, latest February 21, 2025 2025: Labeling · 2024: Labeling · 2021: Labeling |
| NDA018615 SULFATRIM, SULFATRIM PEDIATRIC | Pharm Assoc | January 7, 1983 | 43, latest February 21, 2025 2025: Labeling · 2024: Labeling · 2021: Labeling |
Generic approvals (11)
- ANDA071017Sun Pharm Industries · August 25, 1986
- ANDA073303Teva Pharms USA · October 31, 1991
- ANDA076899Amneal Pharms Ny · January 27, 2005
- ANDA076817Vista Pharms · October 7, 2005
- ANDA077612Prasco · November 13, 2006
- ANDA077785Chartwell Molecular · January 24, 2007
- ANDA078060Chartwell Molecules · January 25, 2007
- ANDA090624Aurobindo Pharma · February 16, 2010
- ANDA091348Aurobindo Pharma · June 8, 2010
- ANDA212231Somerset · June 26, 2019
- ANDA214330Novitium Pharma · February 8, 2022
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.
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September 2, 2025 · Class II · Ongoing · D-0624-2025
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC — The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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September 2, 2025 · Class II · Ongoing · D-0625-2025
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing — The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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August 20, 2025 · Class II · Ongoing · D-0654-2025
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count — Northwind Pharmaceuticals LLC
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August 18, 2025 · Class II · Ongoing · D-0615-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt — Amneal Pharmaceuticals, LLC
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June 2, 2025 · Class I · Ongoing · D-0488-2025
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral S — Amneal Pharmaceuticals, LLC
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April 13, 2022 · Class II · Terminated · D-1059-2022
cGMP deviations: Temperature abuse
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61 — Mckesson Medical-Surgical Inc. Corporate Office
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July 7, 2021 · Class II · Terminated · D-0719-2021
Presence of Foreign Substance- Potential of metal contamination.
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862 — Aurobindo Pharma USA Inc.
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August 10, 2020 · Class II · Terminated · D-1535-2020
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in In — Aurobindo Pharma USA Inc.
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April 19, 2018 · Class II · Terminated · D-0802-2018
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbur — Sun Pharmaceutical Industries, Inc.
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September 27, 2011 · Class II · Terminated · D-1450-2014
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Cent — Shamrock Medical Solutions Group 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
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
- SulfatrimBrand page: products, maker and price
- BactrimBrand page: products, maker and price
- Bactrim DSBrand page: products, maker and price
- Sulfameth/Trimeth-DSBrand page: products, maker and price
- PneumoniaCondition named on the label: hospitals that treat it
- A-S Medication SolutionsMaker or distributor
- Teva Parenteral Medicines, Inc.Maker 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) — Bactrim, Sun Pharmaceutical Industries, Inc, effective December 30, 2024; 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 →