Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP
- Recalling company
- Lupin Pharmaceuticals Inc.
- Product
- Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
- Reason
- Defective container - seal not adhering to bottles
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 5, 2025
- Reported
- Dec 17, 2025
- Distribution
- Nationwide.
- Status
- Ongoing
- Quantity
- 52,128 bottles
- Lot / codes
- Lot # QB00865, exp. date Feb 2028
- Company location
- Naples, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0227-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0227-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.