Chlorpromazine Recall: Amneal 50 mg Tablets
FDA is recalling chlorpromazine hydrochloride tablets, 50 mg, 100-count bottles distributed nationwide due to the presence of a foreign substance from packaging material. A specific lot of auxiliary polyester coil used in packaging was detected with a microorganism; no microorganism was detected on any tablets. About 13,130 bottles are affected across lots AM240147/AM240148 (Exp 01/31/2027) and AM240664/AM240665 (Exp 04/30/2027).
| Brand | Amneal Pharmaceuticals, LLC |
|---|---|
| Product | chlorproMAZINE Hydrochloride Tablets, USP, 50 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 69238-1058-1. |
| Reason | 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. |
| Severity | moderate |
| Units affected | 27936 |
| Distribution | Distributed Nationwide in the USA |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use the recalled product.
- Check your bottle for lot numbers AM240147, AM240148, AM240664, or AM240665; if matched, discontinue use.
- Contact your healthcare provider or pharmacist for guidance and information about returns or replacement.
- If you have experienced any health issues, seek medical advice and report to the appropriate healthcare professional.
How to identify the recalled item
| Lot / date codes | Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027. |
|---|---|
| Lot / date codes | Lot AM251676, EXP 11/31/2028 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other chlorpromazine recalls
- Chlorpromazine Recall: Zydus Lifesciences lot Z403011, Z407335 · 2026-05-27
- Chlorpromazine Recall: AvKare 100 mg · 2026-03-04
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.