Recalls / Class II
Class IID-0616-2025
Product
chlorproMAZINE Hydrochloride Tablets, USP, 25 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 69238-1056-1.
- Brand name
- Chlorpromazine Hydrochloride
- Generic name
- Chlorpromazine Hydrochloride
- Active ingredient
- Chlorpromazine Hydrochloride
- Route
- Oral
- NDCs
- 69238-1054, 69238-1056, 69238-1058, 69238-1060, 69238-1062
- FDA application
- ANDA209755
- Affected lot / code info
- Lot AM240617, AM240618, Exp Date 04/30/2027
Why it was recalled
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.
Recalling firm
- Firm
- Amneal Pharmaceuticals, LLC
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Crossing Blvd Fl 3, N/A, Bridgewater, New Jersey 08807-2863
Distribution
- Quantity
- 7,228 100-count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-08-18
- FDA classified
- 2025-09-04
- Posted by FDA
- 2025-09-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0616-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.