Glenmark Pharmaceuticals Inc., USA 2025-01-01 Health serious FDA
Health · FDA · Recall #FDA-D-0159-2025
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured… Recall
Issued January 1, 2025 · Glenmark Pharmaceuticals Inc., USA
In January 2025, Glenmark Pharmaceuticals Inc., USA recalled the chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
What you should do
- 1 Stop using chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Glenmark Pharmaceuticals Inc., USA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Glenmark Pharmaceuticals Inc., USA
- Category
- Health
- Recall date
- January 1, 2025
- Units affected
- Not reported
- Sold at
- USA Nationwide
- Recall number
- FDA-D-0159-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Glenmark Pharmaceuticals Inc., USA has 53 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.