chlorproMAZINE Hydrochloride Tablets — Class II drug recall D-0618-2025
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-0618-2025 |
|---|---|
| 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 | 69238-1054, 69238-1054-01, 69238-1056, 69238-1056-01, 69238-1058, 69238-1058-01, 69238-1060, 69238-1060-01, 69238-1062, 69238-1062-01 |
| Lot numbers | AM240334, AM240335, AM241031 |
| Expiration dates | 2027-02-28, 2027-06-30 |
Product
chlorproMAZINE Hydrochloride Tablets, USP, 100 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 69238-1060-1.
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-0618-2025. 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.