The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0827-2023·Announced 2023-06-07

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

Related recalls

Same manufacturer · Akorn, Inc.

See all →

Same hazard · potency loss

See all →

Similar recalls