Sulfamethoxazole and Trimethoprim Tablets — Class II drug recall D-0615-2025
Ongoing recall by Amneal Pharmaceuticals, LLC, reported 2025-09-10, distributed nationwide. Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was dete
| Recall number | D-0615-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, LLC, Bridgewater, NJ, United States |
| Recall initiated | 2025-08-18 |
| Classified | 2025-09-04 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| 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 | 2027-01-31, 2027-02-28, 2027-04-30, 2027-05-30, 2027-05-31, 2027-06-30, 2027-07-31, 2027-08-31 |
Product
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. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Reason for recall
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.
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-0615-2025. 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.