FDA Drug recall D-0643-2025
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 3847…
- 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, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 3847… by Avkare, citing presence of a foreign substance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0643-2025 |
| 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, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
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 # 46824, Exp 9/30/25; 47171, Exp 12/31/25 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Avkare
- Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com…
FDA Drug · Class II · 2026-03-04 · Avkare - Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2026-01-14 · Avkare - Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister c…
FDA Drug · Class II · 2025-10-15 · Avkare - chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 384…
FDA Drug · Class II · 2025-09-17 · Avkare - Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class III · 2025-07-09 · Avkare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0643-2025%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.