Medications & Supplements/Prescription Drugs

Mckesson Corporation: Megestrol Acetate Oral Suspension Recalled for Superpotency

Agency Publication Date: September 5, 2018

Summary

McKesson Corporation is recalling 1,531 cartons of Megestrol Acetate Oral Suspension, USP 400 mg/mL, because the medication was found to be superpotent. This means the drug may contain a higher concentration of the active ingredient than specified, which can lead to consumers receiving an incorrect and potentially harmful dose. This recall affects 10 mL unit-dose cups sold in boxes of 20, distributed nationwide within the United States.

Risk

Superpotent medication can result in patients receiving a higher dose of Megestrol Acetate than prescribed, increasing the risk of adverse reactions and hormonal side effects. No specific injuries or incidents have been reported in the recall data.

What You Should Do

Check your medication packaging for Megestrol Acetate Oral Suspension, USP 400 mg/mL (10 mL unit-dose cups in boxes of 20).
Verify if your product matches the affected lot numbers: 0116158 (Expiration 4/30/19), or lot numbers 0113903, 0113902, and 0113901 (Expiration 8/31/18).
Confirm the NDC number on the package is 63739-549-51.
If your medication is part of the recall, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement.
Return any unused product to the pharmacy where it was purchased for a refund and contact McKesson Corporation for further instructions regarding the return process.
For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug recall remedy for superpotent medication

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

Affected Products

Product: Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups)

Model:

NDC 63739-549-51

Recall #: D-1172-2018

Lot Numbers:

0116158 (Exp. 4/30/19)

0113903 (Exp. 8/31/18)

0113902 (Exp. 8/31/18)

0113901 (Exp. 8/31/18)

Date Ranges: Exp. 4/30/19, Exp. 8/31/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80830

Status: Resolved

Manufacturer: Mckesson Corporation

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 1531 cartons

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 · 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.

Summary

What You Should Do

Check your medication packaging for Megestrol Acetate Oral Suspension, USP 400 mg/mL (10 mL unit-dose cups in boxes of 20).

Verify if your product matches the affected lot numbers: 0116158 (Expiration 4/30/19), or lot numbers 0113903, 0113902, and 0113901 (Expiration 8/31/18).

Confirm the NDC number on the package is 63739-549-51.

If your medication is part of the recall, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a replacement.

Return any unused product to the pharmacy where it was purchased for a refund and contact McKesson Corporation for further instructions regarding the return process.

For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).