FDA Drug recall D-0488-2025
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bot…
- FDA Drug
- Class I
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class I recall of Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bot… by Amneal Pharmaceuticals, citing microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0488-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-06-02 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Identifiers
| ndc | 65162-271-05 |
|---|---|
| ndc | 65162-271-10 |
| ndc | 65162-271-50 |
| ndc | 65162-271-11 |
| ndc | 65162-272-01 |
| ndc | 65162-272-24 |
| ndc | 65162-272-10 |
| ndc | 65162-272-25 |
| ndc | 65162-272-50 |
| code_info | Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-04-08 · Amneal Pharmaceuticals - Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufact…
FDA Drug · Class I · 2026-04-08 · Amneal Pharmaceuticals
All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0488-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.