Recalls / Class II
Class IID-0309-2025
Product
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
- Brand name
- Chlorpromazine Hydrochloride
- Generic name
- Chlorpromazine Hydrochloride
- Active ingredient
- Chlorpromazine Hydrochloride
- Route
- Oral
- NDCs
- 68462-861, 68462-862, 68462-863, 68462-864, 68462-865
- FDA application
- ANDA212144
- Affected lot / code info
- Lot#s: 17232222 and 17232237, Exp 10/31/2025
Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 8160 bottles
- Distribution pattern
- Nationwide in the USA and PR
Timeline
- Recall initiated
- 2025-03-11
- FDA classified
- 2025-04-02
- Posted by FDA
- 2025-04-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0309-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.