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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Trazodone Hydrochloride 100mg Tablets Recalled for Dented Surfaces

Agency Publication Date: December 31, 2025
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Summary

Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling one lot of Trazodone Hydrochloride Tablets, USP, 100mg (approximately 2,136 bottles) because some tablets were found to have a dent on the surface. Trazodone is a prescription medication used to treat major depressive disorder. While the recall is low risk, the dented tablets do not meet the product's quality specifications.

Risk

The tablets were recalled due to a physical defect where a dent was found on the plain side of the tablet surface. This physical deformity could potentially affect the integrity or dosing consistency of the medication.

What You Should Do

  1. Check your prescription bottle for Trazodone Hydrochloride Tablets, USP, 100mg, in 1,000-count bottles with NDC 68382-806-10.
  2. Verify if your bottle belongs to Lot # EA00237A with an Expiration Date of 04/30/2027.
  3. 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 the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for 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: Trazodone Hydrochloride Tablets, USP (1,000-count bottle)by Zydus Pharmaceuticals (USA) Inc
Variants: 100mg, Tablet
Lot Numbers:
EA00237A (Exp 04/30/2027)
NDC:
68382-806-10

Recall #: D-0247-2026; Manufactured by: Zydus Lifesciences Ltd., India

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98184
Status: Active
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 2,136 1000-count bottles
Distributed To: Nationwide

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.