Why it was recalled
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Product description
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Lot numbers, UPCs & expiration codes
a) Lot # E408871, Exp Date: 10/2026; Lot # E405282, Exp Date: 06/2026; Lot # E400386, Exp Date: 12/2025 b) Lot # E408872, Exp Date: 10/2026; Lot # E405280, Exp Date: 06/2026 c) Lot # E408873, Exp Date: 10/2026; Lot # E405281, Exp Date: 06/2026; Lot # E400387, Exp Date: 12/2025
Where it was sold
Nationwide in the US
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-0152-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 22, 2025
- FDA report date
- Nov 12, 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-0152-2026, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97856
- Address
- 73 Route 31 N
- Code information
- a) Lot # E408871, Exp Date: 10/2026; Lot # E405282, Exp Date: 06/2026; Lot # E400386, Exp Date: 12/2025 b) Lot # E408872, Exp Date: 10/2026; Lot # E405280, Exp Date: 06/2026 c) Lot # E408873, Exp Date: 10/2026; Lot # E405281, Exp Date: 06/2026; Lot # E400387, Exp Date: 12/2025
- Postal code
- 08534-3601
- Report date
- Nov 12, 2025
- Product type
- Drugs
- Recall number
- D-0152-2026
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Reason for recall
- cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Oct 22, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 4, 2025