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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

Mylan Pharmaceuticals Inc.: Tacrolimus Capsules Recalled for Potential Dosage Mix-Up

Agency Publication Date: March 24, 2020
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Summary

Mylan Pharmaceuticals is recalling 3,816 bottles of Tacrolimus Capsules, USP 5mg (generic Prograf) because a single 1mg capsule may have been accidentally included in a bottle of 5mg capsules. Tacrolimus is an immunosuppressant used to prevent organ rejection in transplant patients, and taking the wrong strength could lead to under-dosing. These prescription capsules were distributed in 100-count bottles nationwide and were manufactured in the United States. If you have this medication, you should immediately check your bottle to ensure all capsules are the correct strength before your next dose.

Risk

If a patient accidentally takes a 1mg capsule instead of their prescribed 5mg dose, they will receive significantly less medication than required. This under-dosing can lead to a decrease in the drug's effectiveness in the body, potentially increasing the risk of organ transplant rejection.

What You Should Do

  1. Check your prescription bottle for Tacrolimus Capsules, USP 5mg, 100-count bottles with NDC 0378-2047-01.
  2. Verify if your bottle belongs to Lot # 3105410 or 3106268 with an expiration date of 9/2020.
  3. Inspect the capsules inside the bottle; if you find any capsule that looks different from the others or appears to be a 1mg strength instead of 5mg, do not take it.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you suspect your medication is affected or if you have already taken a potentially incorrect dose.
  5. Return any unused or affected product to your pharmacy for a refund and contact Mylan Pharmaceuticals for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Tacrolimus Capsules, USP 5mg (100-count bottle)
Model:
NDC 0378-2047-01
Recall #: D-1057-2020
Lot Numbers:
3105410 (Exp 9/2020)
3106268 (Exp 9/2020)
Date Ranges: 9/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85273
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3,816 botlles
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.