Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Megestrol Acetate Oral Suspension Recalled by Breckenridge Pharmaceutical, Inc. Due to Failed Stability Specifications: Out-of-Specification results obtained for particle...

Date: November 6, 2018
Company: Breckenridge Pharmaceutical, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Breckenridge Pharmaceutical, Inc. directly.

Affected Products

Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031

Quantity: 9,193 bottles

Why Was This Recalled?

Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Breckenridge Pharmaceutical, Inc.

Breckenridge Pharmaceutical, Inc. has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report