FDA Drug recall D-0619-2025
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
- FDA Drug
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt by Amneal Pharmaceuticals, citing 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 detecte….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0619-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-18 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
Product
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Reason
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.
Identifiers
| ndc | 69238-1054-1 |
|---|---|
| ndc | 69238-1056-1 |
| ndc | 69238-1058-1 |
| ndc | 69238-1060-1 |
| ndc | 69238-1062-1 |
| code_info | Lot: AM240336, AM240337, Exp Date 02/28/2027. |
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-0619-2025%22
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