CLASS II ONGOING Drug recall · Reported 9 Apr 2025 · FDA Enforcement Report
chlorproMAZINE Hydrochloride Tablets, USP 100 mg recalled
Glenmark Pharmaceuticals Inc., USA is recalling chlorproMAZINE Hydrochloride Tablets, USP 100 mg, distributed nationwide in the US. The recall was initiated on 11 Mar 2025 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-0309-2025
- FDA event ID
- 95658
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2025
- FDA classified
- 2 Apr 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 11 Mar 2025 | Recall initiated by company | |
| 2 Apr 2025 | Classified by FDA | +22 days |
| 9 Apr 2025 | Published in enforcement report | +7 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: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim 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 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
Where it was distributed
Nationwide in the USA and PR
Questions about this recall
Why was it recalled?
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Which lots are affected?
Lot#s: 17232222 and 17232237, Exp 10/31/2025
Where was it sold?
Nationwide in the USA and PR
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.
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 |