chlorproMAZINE Hydrochloride Tablets — Class II drug recall D-0647-2025
Ongoing recall by Amerisource Health Services LLC, reported 2025-09-24, distributed nationwide. Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the m
| Recall number | D-0647-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2025-08-27 |
| Classified | 2025-09-15 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 2,708 cartons |
| NDC | 60687-0419, 60687-0419-01, 60687-0419-11, 60687-0430, 60687-0430-01, 60687-0430-11, 60687-0430-65, 60687-0441, 60687-0441-01, 60687-0441-11, 60687-0452, 60687-0452-01, 60687-0452-11, 60687-0463, 60687-0463-01, 60687-0463-11 |
| Expiration dates | 2026-08-31, 2026-09-30, 2026-10-31, 2026-11-30, 2026-12-31 |
Product
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Reason for recall
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.
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-0647-2025. 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.