Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.…
- Recall date
- November 5, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0227-2026
- FDA classification
- Class II
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide.
Why it was recalled
Defective container - seal not adhering to bottles
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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