FDA Drug recall D-0615-2025
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10
- FDA Drug
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10 by Amneal Pharmaceuticals, citing 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 detecte….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0615-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-18 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
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.
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 a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date…Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Date 6/30/27, AM241086, Exp Date 7/31/27, AM241087, AM241088, Exp Date 8/31/27. |
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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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0615-2025%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.