FDAHealthNovember 5, 2025
Lupin Pharmaceuticals Inc. — Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
⚠️ Defective container - seal not adhering to bottles
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 5, 2025
Nationwide.
What's affected?
- Product
- Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
- Lot code
- QB00865
Additional details
Lot # QB00865, exp. date Feb 2028
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 52,128 bottles.
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