FDA Drugs recall ·
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg… recall
- Recall number
- D-0648-2025
- Date
- (initiated August 27, 2025)
- Company / brand
- Amerisource Health Services LLC
2550 John Glenn Ave Ste A, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,062 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 Dose NDC: 60687-441-11)
Why was it recalled?
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.
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: 1022159, exp 12/31/2026; 1023299, exp 03/31/2027; 1024057, Exp 04/30/2027
Distribution
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-0648-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.