Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
chlorproMAZINE Hydrochloride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Affected NDC
68462-0861-01
Compare with the code on your package — it is the most precise check available.
Drug: Chlorpromazine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Chlorpromazine Hydrochloride NDC 68462-0861 |
10 mg/1 | Tablet, Film Coated Oral |
Glenmark Pharmaceuticals Inc., USA | Rx |
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-861-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0159-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Chlorpromazine recalls
See all
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Class II · Moderate risk
Major ChlorproMAZINE Hydrochloride Tablets
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Other recalls by Glenmark Pharmaceuticals Inc., USA
All 2024 recalls
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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