Amneal Pharmaceuticals, LLC: Drug Recall
Recall #D-0615-2025 · 08/18/2025
Class II: Risk
Recall Details
- Recall Number
- D-0615-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Amneal Pharmaceuticals, LLC
- Status
- Ongoing
- Date Initiated
- 08/18/2025
- Location
- Bridgewater, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60,072 100-count, 73,054 500-count bottles
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.
Product Description
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.
Distribution Pattern
Distributed Nationwide in the USA
Other Recalls by Amneal Pharmaceuticals, LLC
- Class II: Risk 08/18/2025
- Class II: Risk 08/18/2025
- Class II: Risk 08/18/2025
- Class II: Risk 08/18/2025
- Class I: Dangerous 06/02/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.