FDA Drugs recall ·
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only… recall
- Recall number
- D-0227-2026
- Date
- (initiated November 5, 2025)
- Company / brand
- Lupin Pharmaceuticals Inc.
5801 Pelican Bay Blvd, Naples, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 52,128 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Why was it recalled?
Defective container - seal not adhering to bottles
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # QB00865, exp. date Feb 2028
Distribution
Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0227-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.