chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)

FDA recall notice · announced September 24, 2025 · Amerisource Health Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027
Quantity: 873 cartons
Status: Ongoing
Products in this recall event:
- chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Do (D-0648-2025)
- chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual u (D-0649-2025)
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Indivi (D-0647-2025)
- chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC (D-0650-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.