Reported Dec 17, 2025 · Ongoing
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals,…
Lupin Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 5801 Pelican Bay Blvd · Naples, FL · 34108-2755
Is this the product you have?
- Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only
- Manufactured byLupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09
- Lot codes and dates
Lot # QB00865exp. date Feb 2028
- Amount recalled
- 52,128 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Defective container - seal not adhering to bottles
This product could cause temporary or reversible health problems — stop using it.
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