Stimulant Recalled

Citing the possibility bottles may contain tablets of mixed strengths, Teva Pharmaceuticals USA is voluntarily recalling 100-count bottles of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets (mixed amphetamine salts product). The recall was included in the June 10, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The following products, distributed throughout the United States and in Puerto Rico, were included in the recall:

• 5-mg dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets in 100-count bottles (NDC 0555-0971-02) from lot 42614718 (Exp. 2/21);
• 15-mg dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets in 100-count bottles (NDC 0555-0777-02) from lot 42617008 (Exp. 10/21); and
• 20-mg dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets in 100-count bottles (NDC 0555-0973-02) from lot 42617891 (Exp. 1/22).

Teva Pharmaceuticals initiated the recalls May 22, 2020. The FDA designated the recalls Class II on June 4, 2020, signaling use of the tablets could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

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

—Jolynn Tumolo