Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Dextroamphetamine Sulfate Extended Release Capsules Recalled by Amedra Pharmaceuticals LLC Due to Failed Dissolution Specifications: The affected lots may not...

Date: December 4, 2012
Company: Amedra Pharmaceuticals LLC
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 Amedra Pharmaceuticals LLC directly.

Affected Products

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09

Quantity: 10,968 bottles

Why Was This Recalled?

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Amedra Pharmaceuticals LLC

Amedra Pharmaceuticals LLC has 4 total recalls tracked by RecallDetector.

Related Recalls

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