chloroproMAZINE Hydrochloride Tablets — Class II drug recall D-0643-2025
Ongoing recall by AvKARE, reported 2025-09-17, distributed nationwide. Presence of a foreign substance.
| Recall number | D-0643-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2025-08-25 |
| Classified | 2025-09-11 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,512 cartons |
| NDC | 50268-0162, 50268-0162-11, 50268-0162-15, 50268-0163, 50268-0163-11, 50268-0163-15, 50268-0164, 50268-0164-11, 50268-0164-15, 50268-0165, 50268-0165-11, 50268-0165-15, 50268-0166, 50268-0166-11, 50268-0166-12 |
| Lot numbers | 46824, 47171 |
| Expiration dates | 2025-09-30, 2025-12-31 |
Product
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Reason for recall
Presence of a foreign substance.
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-0643-2025. 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.