Why it was recalled
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Product description
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
Lot numbers, UPCs & expiration codes
Lot#: PA07434, Exp. May 2026.
Where it was sold
Nationwide within U.S
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-0515-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 29, 2026
- FDA report date
- May 13, 2026
- Quantity
- 77,376 packs.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ajanta Pharma Ltd.
Original FDA data
Every field from FDA enforcement report D-0515-2026, exactly as published.
Show all FDA fields
- City
- Aurangabad
- Status
- Ongoing
- Country
- India
- Event ID
- 98785
- Address
- B-4/5/6 MIDC Industrial Area
- Address (line 2)
- Paithan
- Code information
- Lot#: PA07434, Exp. May 2026.
- Report date
- May 13, 2026
- Product type
- Drugs
- Recall number
- D-0515-2026
- Classification
- Class II
- Recalling firm
- Ajanta Pharma Ltd.
- Product quantity
- 77,376 packs.
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
- Distribution pattern
- Nationwide within U.S
- Recall initiation date
- Apr 29, 2026
- Initial firm notification
- Letter
- Center classification date
- May 4, 2026