Medications & Supplements/Prescription Drugs

Lannett Company, Inc.: Prednisone 2.5 mg Recalled Due to Label Mix-Up with 10 mg Tablets

Agency Publication Date: August 17, 2020

Summary

Lannett Company, Inc. has initiated a voluntary recall of one batch of Prednisone Tablets, USP 2.5 mg because the bottles may actually contain Prednisone Tablets, USP 10 mg. This label mix-up means patients could unknowingly take four times the prescribed dose of this steroid medication. Approximately one batch (Batch Number PE190701e1) of 100-count bottles is affected by this error. Consumers should immediately check their medication bottles to see if they match the affected batch and contact their healthcare provider.

Risk

Taking 10 mg of Prednisone when a 2.5 mg dose is prescribed results in a 400% overdose. This can lead to serious adverse health effects depending on the patient's condition and the duration of the higher dose, including immunosuppression, blood sugar spikes, and mood changes.

What You Should Do

Check your medication bottle for Prednisone Tablets, USP 2.5 mg (100 tablets) with NDC 0527-2931-37.
Verify if your bottle belongs to Batch Number PE190701e1 with an expiration date of June 2021.
If your bottle matches these details, do not take any more medication from the bottle and immediately contact your pharmacist or healthcare provider for guidance on how to safely transition to the correct dose.
Return any unused tablets from the affected batch to your pharmacy for a refund and to ensure you receive the correct 2.5 mg strength.
Contact Lannett Company, Inc. directly for further instructions regarding this recall at their Philadelphia headquarters.
For additional questions or to report side effects, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Prednisone Tablets, USP 2.5 mg (100 tablets)

Model:

NDC 0527-2931-37

Lot Numbers:

Batch Number PE190701e1 (Exp June 2021)

Date Ranges: June 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86130

Status: Resolved

Manufacturer: Lannett Company, Inc.

Sold By: pharmacies

Manufactured In: China, United States

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 bottle for Prednisone Tablets, USP 2.5 mg (100 tablets) with NDC 0527-2931-37.

Verify if your bottle belongs to Batch Number PE190701e1 with an expiration date of June 2021.

If your bottle matches these details, do not take any more medication from the bottle and immediately contact your pharmacist or healthcare provider for guidance on how to safely transition to the correct dose.

Return any unused tablets from the affected batch to your pharmacy for a refund and to ensure you receive the correct 2.5 mg strength.

Contact Lannett Company, Inc. directly for further instructions regarding this recall at their Philadelphia headquarters.

For additional questions or to report side effects, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.