Medications & Supplements/Prescription Drugs

Sertraline Tablets Recalled for Potential Medication Comingling

Agency Publication Date: December 26, 2023

Summary

Legacy Pharmaceutical Packaging LLC has recalled 161,664 bottles of Sertraline Tablets, USP 100 mg (30 count per bottle). These medications were manufactured for Cipla USA, Inc. and distributed through Wal-Mart stores in California and Arkansas. The recall was issued due to packaging issues that may have resulted in different medications being mixed together in the same bottle.

Risk

If different medications are mixed into a bottle of Sertraline, a patient might accidentally take the wrong drug. This could lead to serious health issues from unintended drug interactions or the failure to treat the patient's primary medical condition.

What You Should Do

The recalled product is Sertraline Tablets, USP 100 mg, sold in 30-count bottles (NDC 68645-523-54) and distributed through Wal-Mart locations in California and Arkansas.
Check your bottle for lot number 222033 with an expiration date of 08/31/2024 to determine if your medication is part of the recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Legacy Pharmaceutical Packaging LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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 Tablets, USP (30 count)

Variants: 100 mg, 30 tablets per bottle

Lot Numbers:

222033 (Exp 08/31/2024)

NDC:

68645-523-54

Distributed by: Wal-Mart, Bentonville, AR; Manufactured for: Cipla USA, Inc., Warren, NJ; Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93605

Status: Active

Manufacturer: Legacy Pharmaceutical Packaging LLC

Sold By: Wal-Mart

Manufactured In: United States

Units Affected: 161,664 bottles

Distributed To: California, Arkansas

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 · 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.

Summary

What You Should Do

The recalled product is Sertraline Tablets, USP 100 mg, sold in 30-count bottles (NDC 68645-523-54) and distributed through Wal-Mart locations in California and Arkansas.

Check your bottle for lot number 222033 with an expiration date of 08/31/2024 to determine if your medication is part of the recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Legacy Pharmaceutical Packaging LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.