FDA Drug recall D-0644-2025
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 384…
- FDA Drug
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 384… by Avkare, citing presence of a foreign substance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0644-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-25 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Reason
Presence of a foreign substance.
Identifiers
| ndc | 50268-162-11 |
|---|---|
| ndc | 50268-162-15 |
| ndc | 50268-163-11 |
| ndc | 50268-163-15 |
| ndc | 50268-164-11 |
| ndc | 50268-164-15 |
| ndc | 50268-165-11 |
| ndc | 50268-165-15 |
| ndc | 50268-166-11 |
| ndc | 50268-166-12 |
| code_info | Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0644-2025%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.