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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sertraline Hydrochloride 100 mg Tablets Recalled for Defective Bottle Seal

Agency Publication Date: December 10, 2025
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Summary

Lupin Pharmaceuticals Inc. is recalling 52,128 bottles of Sertraline Hydrochloride Tablets USP (100 mg), commonly known as Zoloft. The recall was initiated because the container seal is not properly adhering to the bottles, which could compromise the integrity of the medication. Each recalled bottle contains 90 tablets and was distributed nationwide.

Risk

A defective seal may allow air or moisture to enter the bottle, potentially reducing the effectiveness of the medication or leading to contamination. This is particularly concerning for patients relying on consistent dosing for mental health conditions.

What You Should Do

  1. Check your medication bottle for Sertraline Hydrochloride Tablets USP, 100 mg (90-count bottles) with NDC 68180-353-09 and Lot # QB00865 with an expiration date of February 2028.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sertraline Hydrochloride Tablets USP, 100 mg (90 Tablets bottles)
Variants: 100 mg, 90 Tablets
Lot Numbers:
QB00865 (Exp Feb 2028)
NDC:
68180-353-09

Rx Only; Manufactured by Lupin Pharmaceuticals, Inc., Naples, FL 34108

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97936
Status: Active
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 52,128 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.