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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

American Health Packaging: Sirolimus Tablets Recalled for Failed Impurity and Degradation Specifications

Agency Publication Date: September 20, 2021
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Summary

American Health Packaging has recalled approximately 290 cartons of Sirolimus (1 mg) tablets because the product failed to meet quality standards for impurities and degradation during testing. Sirolimus is a prescription medication used to prevent organ rejection in patients who have received kidney transplants. Consumers should not stop taking their medication without first consulting a healthcare professional, as doing so could pose serious health risks.

Risk

The failure to meet impurity and degradation specifications means the medication may contain chemical byproducts or lose its potency over time. This could potentially reduce the effectiveness of the drug in preventing organ rejection or cause unexpected side effects.

What You Should Do

  1. Check your prescription packaging for Sirolimus Tablets 1 mg with NDC 68084-915-25.
  2. Verify if your medication belongs to Lot # 1000789 with an expiration date of 10/31/2022.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and arrange for a replacement medication before you stop taking the recalled tablets.
  4. Return any unused product from the affected lot to the pharmacy or place of purchase for a refund.
  5. Contact the manufacturer, American Health Packaging, if you have additional questions regarding the return process.
  6. For further assistance, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and guidance from healthcare professionals

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

Affected Products

Product: Sirolimus Tablets 1 mg (30 Tablets)
Model:
NDC 68084-915-25
Recall #: D-0813-2021
Lot Numbers:
1000789 (Exp. Date 10/31/2022)
Date Ranges: 10/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88650
Status: Resolved
Manufacturer: American Health Packaging
Manufactured In: United States
Units Affected: 290 cartons
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.