Megestrol Acetate Oral Suspension Recalled for Incomplete Stability Studies
Akorn recalled all lots of Megestrol Acetate Oral Suspension nationwide due to the firm's inability to complete required stability studies after ceasing operations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is theoretical—incomplete stability studies—rather than confirmed product degradation or harm. Per the rubric, theoretical hazards with no reported adverse effects score at most 3.
Plain-English summary
Akorn, Inc. is recalling all lots of Megestrol Acetate Oral Suspension, USP 40 mg/mL in 240 mL bottles. The product was distributed nationwide in the USA and Puerto Rico under all NDC codes.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing firm ceased operations and could no longer continue the stability studies required to verify product safety. Stability studies are essential regulatory requirements to ensure a medication maintains its safety and potency throughout its shelf life.
Patients currently taking this medication should contact their healthcare provider or pharmacist. The FDA and the recalling firm recommend that patients obtain guidance on continuity of care before discontinuing use.
The recalled product
- Product
- Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Oral Suspension
- Hazard
- potency-loss
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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