Sulfamethoxazole and Trimethoprim Tablets recall
FDA recall D-0488-2025 · initiated Jun 2, 2025
Amneal Pharmaceuticals, LLC recalled Sulfamethoxazole and Trimethoprim Tablets in Jun 2025 — an FDA Class I recall (D-0488-2025) because Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6396 bottles
Details
- Product
- 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 Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
- Recalling company
- Amneal
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 2, 2025
- FDA report date
- Jun 18, 2025
Frequently asked
- Was Sulfamethoxazole and Trimethoprim Tablets recalled?
- Amneal Pharmaceuticals, LLC recalled Sulfamethoxazole and Trimethoprim Tablets in Jun 2025 — an FDA Class I recall (D-0488-2025) because Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Sulfamethoxazole and Trimethoprim Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0488-2025 was: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
- Is a recalled Sulfamethoxazole and Trimethoprim Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sulfamethoxazole and Trimethoprim Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0488-2025.