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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

Breckenridge Pharmaceutical, Inc.: Megestrol Acetate Oral Suspension Recalled for Stability Issues

Agency Publication Date: November 15, 2018
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Summary

Breckenridge Pharmaceutical, Inc. is recalling approximately 9,193 bottles of Megestrol Acetate Oral Suspension, USP 625 mg/5mL (generic for Megace ES). The recall was initiated because the medication failed stability testing for particle size distribution, which means the drug particles in the suspension may not be the correct size. Consumers who have these specific bottles should contact their healthcare provider or pharmacist for guidance, as the medication may not work as intended.

Risk

Incorrect particle size distribution in an oral suspension can affect how the body absorbs the medication, potentially leading to inconsistent dosing or reduced effectiveness of the treatment.

What You Should Do

  1. Check your medication bottle to see if it is Megestrol Acetate Oral Suspension, USP 625 mg/5mL in a 150 mL bottle, manufactured by Pharmaceutics International Inc. for Breckenridge Pharmaceutical, Inc.
  2. Verify if your bottle matches one of the following affected lots and expiration dates: Lot 5599.008A, 5599.009A, or 5599.010A (Exp. 04/2019); Lot 5599.012A or 5599.013A (Exp. 11/2019); or Lot 5599.014A (Exp. 01/2020).
  3. If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options and ensure you do not miss necessary doses.
  4. Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.
  5. Contact Breckenridge Pharmaceutical, Inc. at their Boca Raton headquarters for further instructions regarding this recall.
  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

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

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 625 mg/5mL (150 mL bottle)
Model:
Recall #: D-0279-2019
Lot Numbers:
5599.008A (Exp. 04/2019)
5599.009A (Exp. 04/2019)
5599.010A (Exp. 04/2019)
5599.012A (Exp. 11/2019)
5599.013A (Exp. 11/2019)
5599.014A (Exp. 01/2020)
5599
Date Ranges: Exp. 04/2019, Exp. 11/2019, Exp. 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81523
Status: Resolved
Manufacturer: Breckenridge Pharmaceutical, Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 9,193 bottles
Distributed To: Nationwide
Agency Last Updated: November 20, 2018

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.