Why it was recalled
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Product description
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Lot numbers, UPCs & expiration codes
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Where it was sold
US Nationwide.
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-0555-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 14, 2026
- FDA report date
- Jun 10, 2026
- Quantity
- 50 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Asclemed USA Inc.
Original FDA data
Every field from FDA enforcement report D-0555-2026, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 99019
- Address
- 379 Van Ness Ave Ste 1403
- Code information
- Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
- Postal code
- 90501-7211
- Report date
- Jun 10, 2026
- Product type
- Drugs
- Recall number
- D-0555-2026
- Classification
- Class II
- Recalling firm
- Asclemed USA Inc.
- Product quantity
- 50 bottles
- Reason for recall
- CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 14, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 2, 2026