Reported Sep 10, 2025 · Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals…
Amneal Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amneal Pharmaceuticals, LLC · 400 Crossing Blvd Fl 3 · Bridgewater, NJ · 08807-2863
Is this the product you have?
- chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only
- Manufactured byAmneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA
- Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1
- Lot codes and dates
- Lot
AM240147AM240148Exp Date 01/31/2027Lot AM240664AM240665Exp Date 04/30/2027
- Lot
- Amount recalled
- 13,130 100-count bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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