CLASS II ONGOING Drug recall · Reported 17 Sep 2025 · FDA Enforcement Report
Chlorpromazine Hydrochloride Tablets, USP, 50 mg recalled
Zydus Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 3 Sep 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-0634-2025
- FDA event ID
- 97534
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Sep 2025
- FDA classified
- 10 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Nitrosamine Impurity
Timeline
| 3 Sep 2025 | Recall initiated by company | |
| 10 Sep 2025 | Classified by FDA | +7 days |
| 17 Sep 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 above the recommended acceptable intake 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, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Which lots are affected?
Lot #: Z306327, Exp Date 30-11-25; Z306748, Exp Date 30-11-25; Z401154, Exp Date 28-02-26; Z403738, Exp Date 31-05-26; Z405645, Exp Date 30-09-26
Where was it sold?
Nationwide in the USA
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
9 other products · FDA event 97534More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Chlorpromazine recalls
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |