Breckenridge Pharmaceutical, Inc. recalls Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical,
Breckenridge Pharmaceutical recalls Megestrol Acetate Oral Suspension (625 mg/5mL) due to failed stability testing. This prescription drug may have particle size issues affecting safety.
Recall notice
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Contact the company & request your remedy
What happened, in plain English
Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension (625 mg/5mL, 150mL bottle) because stability testing showed particle size problems. This could affect the drug's safety and effectiveness for patients using it under prescription. Read more at govinfonow.com/recall/39441-breckenridge-megestrol-acetate-oral-suspension-recall-stability-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/39441-breckenridge-megestrol-acetate-oral-suspension-recall-stability-issues · Updated October 5, 2026 · FDA enforcement record: FDA #D-0279-2019
Cite this page
“Breckenridge Megestrol Acetate Oral Suspension Recall: Stability Issues.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39441-breckenridge-megestrol-acetate-oral-suspension-recall-stability-issues. Based on FDA recall #D-0279-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0279-2019%22&limit=1).
Why it’s dangerous
The drug failed stability testing for particle size distribution. This means the medication may not be safe or effective as intended, potentially causing health issues for patients using it.
Who’s affected
Patients prescribed Megestrol Acetate Oral Suspension by a doctor are affected. Those using the product from specific lots and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check the product label for the brand name 'Breckenridge Pharmaceutical' and the specific lot numbers: 5599.008A, 5599.009A, 5599.010A (expiring 04/2019), 5599.012A, 5599.013A (expiring 11/2019), or 5599.014A (expiring 01/2020).
- Brand
Breckenridge Pharmaceutical- Category
Drug
What to do — step by step
Check Product Label
Look for the lot numbers 5599.008A, 5599.009A, 5599.010A (expiring 04/2019), 5599.012A, 5599.013A (expiring 11/2019), or 5599.014A (expiring 01/2020) on the bottle.
Questions people ask
Is this product safe to use?
The recall states the product failed stability testing for particle size distribution, which could affect safety and effectiveness. The official notice does not specify if it is safe to use.
What should I do if I have this product?
The recall does not provide a remedy or specific action steps for affected products. The official notice does not say what to do with the product.
How can I tell if I have the recalled product?
Check the product label for the lot numbers: 5599.008A, 5599.009A, 5599.010A (expiring 04/2019), 5599.012A, 5599.013A (expiring 11/2019), or 5599.014A (expiring 01/2020).
Contact Breckenridge Pharmaceutical
We’ve drafted a message you can send Breckenridge Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0279-2019 — Breckenridge Pharmaceutical Breckenridge Pharmaceutical Hello, I own a Breckenridge Pharmaceutical that is covered by recall D-0279-2019 from Breckenridge Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0279-2019 (November 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0279-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.