FDAFDA · Food and drugs·Recall number D-0617-2025
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.
Published September 10, 2025 · Recall initiated: August 18, 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 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
- Amneal Pharmaceuticals, LLC
- Distributor
- Distributed Nationwide in the USA
- UPC
- 0369238105612
- Lot
- Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.