FDAFDA · Food and drugs·Recall number D-0227-2026
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Published December 17, 2025 · Recall initiated: November 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective container - seal not adhering to bottles
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SERTRALINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide.
- Lot
- Lot # QB00865, exp. date Feb 2028
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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