FDAFDA · Food and drugs·Recall number D-0647-2025
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.
Published September 24, 2025 · Recall initiated: August 27, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot: a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026 Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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