Safety Alert: Class II: 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.
healthClass IIRecalled on Sep 10, 2025
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt
🔢 14,923 100-count bottles
Sold At: Amneal Pharmaceuticals, LLC(Distributed Nationwide in the USA)
Recall #: FDA-DRUG-D-0618-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.
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Summary
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 next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Amneal Pharmaceuticals, LLC for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.