Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sertraline Hydrochloride Tablets USP Recalled by Lupin Pharmaceuticals Inc. Due to Defective container - seal not adhering to bottles

Date: November 5, 2025
Company: Lupin Pharmaceuticals Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lupin Pharmaceuticals Inc. directly.

Affected Products

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

Quantity: 52,128 bottles

Why Was This Recalled?

Defective container - seal not adhering to bottles

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report