FDA Drug recall D-0649-2025
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging,…
- FDA Drug
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging,… by Amerisource Health Services, citing presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0649-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-27 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Identifiers
| ndc | 60687-419-11 |
|---|---|
| ndc | 60687-419-01 |
| ndc | 60687-430-11 |
| ndc | 60687-430-01 |
| ndc | 60687-430-65 |
| ndc | 60687-441-11 |
| ndc | 60687-441-01 |
| ndc | 60687-452-11 |
| ndc | 60687-452-01 |
| ndc | 60687-463-11 |
| ndc | 60687-463-01 |
| code_info | Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027 |
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-0649-2025%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.