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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

Dr. Reddy's Tacrolimus Capsules Recalled for Incorrect Dosage Strength

Agency Publication Date: February 21, 2023
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Summary

Dr. Reddy's Laboratories, Inc. is recalling 4,320 bottles of Tacrolimus Capsules, USP (0.5 mg), an immunosuppressant medication used to prevent organ rejection. This recall was initiated after a single 1 mg capsule was discovered inside a bottle labeled as containing only 0.5 mg capsules. The affected 100-count bottles were distributed nationwide in the United States.

Risk

Taking a 1 mg capsule instead of the prescribed 0.5 mg dose could cause a patient to ingest double their intended dosage. This may lead to tacrolimus toxicity, which can result in serious health complications, including kidney impairment or neurological issues.

What You Should Do

  1. This recall affects Dr. Reddy's Tacrolimus Capsules, USP, 0.5 mg strength, distributed in 100-count bottles with NDC 55111-525-01.
  2. Check your medication bottle for lot number C2106445 with an expiration date of 03/2024.
  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 Dr. Reddy's Laboratories, 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: Tacrolimus Capsules, USP, 0.5 mg (100-count bottle)
Variants: 0.5 mg, Capsule
Lot Numbers:
C2106445 (Exp. 03/2024)
NDC:
55111-525-01

Mfd. by Dr. Reddy's Laboratories Limited, Bachupally, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91661
Status: Active
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Pharmacies
Manufactured In: India
Units Affected: 4,320 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.