Recalls / Class II
Class IID-0227-2026
Product
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
- Brand name
- Sertraline Hydrochloride
- Generic name
- Sertraline Hydrochloride
- Active ingredient
- Sertraline Hydrochloride
- Route
- Oral
- NDCs
- 68180-351, 68180-352, 68180-353, 68180-978, 68180-986, 68180-992
- FDA application
- ANDA077670
- Affected lot / code info
- Lot # QB00865, exp. date Feb 2028
Why it was recalled
Defective container - seal not adhering to bottles
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5801 Pelican Bay Blvd, Suite 500, Naples, Florida 34108-2755
Distribution
- Quantity
- 52,128 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2025-11-05
- FDA classified
- 2025-12-10
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0227-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.