Amneal Pharmaceuticals, LLC: Drug Recall
Recall #D-0617-2025 · 08/18/2025
Class II: Risk
Recall Details
- Recall Number
- D-0617-2025
- 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
- 13,130 100-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
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.
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.