Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Reported: December 17, 2025 Initiated: November 5, 2025 #D-0227-2026
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.
Reason for Recall
Defective container - seal not adhering to bottles
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 52,128 bottles
- Distribution
- Nationwide.
- Location
- Naples, FL
Frequently Asked Questions
What product was recalled? ▼
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 52,128 bottles.
Why was this product recalled? ▼
Defective container - seal not adhering to bottles
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 17, 2025. Severity: Moderate. Recall number: D-0227-2026.
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