ADHD Capsules Recalled

ANI Pharmaceuticals Inc. is voluntarily recalling dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules. According to the October 28, 2020, US Food and Drug Administration (FDA) Enforcement Report, the product label lists an incorrect 24-month expiration rather than the correct 18-month expiration. 

The following products, manufactured for Amerigen Pharmaceuticals Inc. and distributed throughout the United States, were included in the recall:

• 5-mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules in 100-count bottles (NDC 43975-277-10) from lot 19S07 (Exp. 9/21);
• 10-mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules in 100-count bottles (NDC 43975-278-10) from lots 19S10 (Exp. 9/21) and 19S11 (Exp. 10/21);
• 15-mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules in 100-count bottles (NDC 43975-279-10) from lots 19T14 (Exp. 12/21) and 20D06 (Exp. 4/22);
• 20-mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules in 100-count bottles (NDC 43975-280-10) from lots 19T15 (Exp. 12/21), 20D02 (Exp. 3/22), and 20D03 (Exp. 3/22);
• 25-mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules in 100-count bottles (NDC 43975-281-10) from lots 19T16 (Exp. 1/22); and
• 30-mg dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules in 100-count bottles (NDC 43975-282-10) from lots 19T17 (Exp. 12/21), 19T18 (Exp. 1/22), 19T19 (Exp. 1/22), 20D05 (Exp. 4/22), and 20D21 (Exp. 5/22).

ANI Pharmaceuticals initiated the recalls October 9, 2020. The FDA designated them Class III on October 21, 2020. Under the classification, use of the recalled capsules is not likely to cause harm. 

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsules are available with a prescription for the treatment of attention-deficit/hyperactivity disorder.

—Jolynn Tumolo