Class II
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
- Recall number
- D-0159-2025
- Report date
- January 1, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Generic names
- CHLORPROMAZINE HYDROCHLORIDE
- Brand names
- CHLORPROMAZINE HYDROCHLORIDE
- Product NDCs
- 68462-861, 68462-862, 68462-863, 68462-864, 68462-865
Code and lot information
Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
Distribution
USA Nationwide
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.