Why it was recalled
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Product description
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
Lot numbers, UPCs & expiration codes
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 it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0634-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 3, 2025
- FDA report date
- Sep 17, 2025
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0634-2025, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97534
- Address
- 73 Route 31 N
- Code information
- 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
- Postal code
- 08534-3601
- Report date
- Sep 17, 2025
- Product type
- Drugs
- Recall number
- D-0634-2025
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Reason for recall
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 3, 2025
- Center classification date
- Sep 10, 2025