It's the second time in recent weeks the company's been involved in a “product mix-up," this time with a generic of a name brand drug.
Attention-deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed and treated neurodevelopmental disorders in the United States, affecting an estimated 7 million children and 15.5 million adults, according to national heath data. While there’s no cure for the disorder, “treatments like medications and behavioral therapies can help manage symptoms,” reports the Cleveland Clinic.
However, those relying on one commonly prescribed medication should consider sweeping their medicine cabinets. Citing a “product mix-up,” the U.S. Food & Drug Administration (FDA) warns that 4,848 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets—a generic form of the popular ADHD drug Adderall—are being recalled due to the wrong dosage of medication.
As explained in the report, two 100-count bottles “labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg” apparently contained one capsule that was actually 5 milligrams of the same medication. Though it’s not immediately clear in the provided details why such a large number of bottles have been affected as a result, the recall reason suggests some consumers may have taken a lower dose than what was prescribed.
The drug, produced and distributed by Lannett Company, Inc. of Seymour, IN, was distributed in a single state: Ohio. The FDA also provided the following details:
- National Drug Code (NDC): 0527-0762-37
- Lot Number: 25283185A
- Expiry: 02/28/2027
- Distributed by: Lannett Company, Inc., Philadelphia, PA 19136
- Available by Rx only
This is not the first time Lannett Company has recalled ADHD medications over a labeling mix-up in recent months. In August, the FDA announced the nationwide recall of 8,544 bottles of Lisdexamfetamine Dimesylate capsules, a generic for brand names such as Vyvanse or Arynta, explaining that the products were labeled as containing 40mg doses, but actually contained 30mg doses.
The current incident, first initiated on August 19, has not yet been classified to reflect a risk level. However, the previous recall event was labeled as a Class II, the second level in a three-tier system used to inform the public of health risks.
In recent decades, ADHD awareness and diagnosis rates have “seen a consistent rise,” according to a 2022 report published in the Missouri Medicine journal. In addition to medication, treatment often includes behavioral and educational therapy. As understanding of ADHD evolves, the national conversation continues to shift toward viewing it not just as a disorder, but as a complex, lifelong condition requiring nuanced support and inclusive approaches.
For daily wellness updates, subscribe to The Healthy by Reader’s Digest newsletter and follow The Healthy on Facebook and Instagram. Keep reading:
- A Beef Product Just Received a Health Alert Across One U.S. Region: FDA
- More Than 133,000 Bottles of a Common Antibiotic Have Been Recalled Nationwide
- Milk Was Recalled from Some of the Country’s Biggest Grocers—and the Near-30,000 Containers Tell a Story
- A Cheese Recall Was Just Expanded to 3 More States and a Walmart Brand
