Sulfamethoxazole and Trimethoprim Tablets — Class I drug recall D-0488-2025
Ongoing recall by Amneal Pharmaceuticals, LLC, reported 2025-06-18, distributed nationwide. Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contaminatio
| Recall number | D-0488-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, LLC, Bridgewater, NJ, United States |
| Recall initiated | 2025-06-02 |
| Classified | 2025-06-23 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 6,396 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 65162-0271, 65162-0271-05, 65162-0271-10, 65162-0271-11, 65162-0271-50, 65162-0272, 65162-0272-01, 65162-0272-10, 65162-0272-24, 65162-0272-25, 65162-0272-50 |
| Expiration dates | 2027-06-30 |
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.
Reason for recall
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0488-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.