Class II
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.
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.
- Recall number
- D-0616-2025
- Report date
- September 10, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Generic names
- CHLORPROMAZINE HYDROCHLORIDE
- Brand names
- CHLORPROMAZINE HYDROCHLORIDE
- Product NDCs
- 69238-1054, 69238-1056, 69238-1058, 69238-1060, 69238-1062
Code and lot information
Lot AM240617, AM240618, Exp Date 04/30/2027
Distribution
Distributed Nationwide in the USA
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.