FDA Drugs recall ·
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle… recall
- Recall number
- D-0618-2025
- Date
- (initiated August 18, 2025)
- Company / brand
- Amneal Pharmaceuticals, LLC
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14,923 100-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
chlorproMAZINE Hydrochloride Tablets, USP, 100 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 69238-1060-1.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.
Distribution
Distributed Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0618-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.