CLASS II ONGOING Drug recall · Reported 1 Jan 2025 · FDA Enforcement Report
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalled
Glenmark Pharmaceuticals Inc., USA is recalling chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 11 Dec 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0160-2025
- FDA event ID
- 95936
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2024
- FDA classified
- 23 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 11 Dec 2024 | Recall initiated by company | |
| 23 Dec 2024 | Classified by FDA | +12 days |
| 1 Jan 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Which lots are affected?
Lot#: 17230133, Exp 12/31/2024
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95936This product is part of a recall event; the main page for the event is chlorproMAZINE Hydrochloride Tablets, USP, 10mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 10mg recalledChlorpromazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Chlorpromazine recalls
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalled | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalled | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalled | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalled | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |