Class III โ€” Low Risk

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

Dextroamphetamine Saccharate Recalled by ANI Pharmaceuticals, Inc. Due to Labeling: Incorrect expiration date. Product dated with 24-month...

Date: October 9, 2020
Company: ANI Pharmaceuticals, 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 ANI Pharmaceuticals, Inc. directly.

Affected Products

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10

Quantity: 408 bottles

Why Was This Recalled?

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

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