Why it was recalled
Defective container - seal not adhering to bottles
Product description
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Lot numbers, UPCs & expiration codes
Lot # QB00865, exp. date Feb 2028
Where it was sold
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-0227-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 5, 2025
- FDA report date
- Dec 17, 2025
- Quantity
- 52,128 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0227-2026, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 97936
- Address
- 5801 Pelican Bay Blvd
- Address (line 2)
- Suite 500
- Code information
- Lot # QB00865, exp. date Feb 2028
- Postal code
- 34108-2755
- Report date
- Dec 17, 2025
- Product type
- Drugs
- Recall number
- D-0227-2026
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 52,128 bottles
- Reason for recall
- Defective container - seal not adhering to bottles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 10, 2025