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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

Trazodone Hydrochloride Recalled for Presence of Foreign Tablets or Capsules

Agency Publication Date: February 5, 2026
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Summary

Granules Pharmaceuticals Inc. is recalling 71,424 bottles of Trazodone Hydrochloride (50 mg), a prescription medication used to treat depression. The recall was initiated because bottles may contain foreign tablets or capsules that are not the intended medication. If you are taking this medication, check your bottle immediately to ensure it only contains the correct tablets.

Risk

Taking a foreign tablet or capsule instead of the prescribed Trazodone could lead to serious adverse health effects, including unintended drug interactions or toxic reactions to an unknown substance.

What You Should Do

  1. Check your bottle for Trazodone Hydrochloride, USP, 50 mg, 100-count bottles with NDC 70010-231-01 and Batch # 6160008A with an expiration date of 12/31/2026.
  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 Granules Pharmaceuticals Inc. 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, USP (100-Count Bottle)by Granules Pharmaceuticals Inc.
Variants: 50 mg, Tablet
Lot Numbers:
6160008A (Exp 12/31/2026)
NDC:
70010-231-01

Manufactured by Granules India Limited; Manufactured for Granules Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98345
Status: Active
Manufacturer: Granules Pharmaceuticals Inc.
Sold By: Retail Pharmacies
Manufactured In: India, United States
Units Affected: 71424 bottles.
Distributed To: Nationwide
Agency Last Updated: February 11, 2026

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.