Nearly 1.5 Million Bottles of ADHD Medication Recalled Nationwide

Amid news that Medicare will be changing its telehealth access including some mental health services for many users starting April 1—along with the White House’s upcoming assessment announced February 13 on some mental health medications—comes an update on a recall for a commonly prescribed drug to treat attention deficit hyperactive disorder.

The recall affects 1,476,048 total bottles of multiple dosages of atomoxetine capsules. Also known by the brand name Strattera and only available via prescription, atomoxetine may be prescribed to treat children, teenagers, and adults with attention-deficit hyperactivity disorder (ADHD). On February 20 the recall was announced to have been categorized as a Class II event, meaning the FDA has determined the drug “may cause temporary or medically reversible adverse health effects” following the original January 29 recall.

The Mayo Clinic explains that atomoxetine “works in the brain to increase attention and decrease restlessness in people who are hyperactive, have problems with concentration, or are easily distracted.” The recall reason is listed as “CGMP Deviations,” which means the product did not meet the FDA’s standards for Current Good Manufacturing Practices—specifically, the “presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.”

September 2024 guidance from the FDA took a closer look at nitrosamine impurities in human drugs, with their analysis stating: “The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.” The Cleveland Clinic explains that carcinogens are known as substances that can increase one’s cancer risk.

Atomoxetine is part of the selective norepinephrine reuptake inhibitors (SNRIs) medication group, which are also prescribed to treat depression but can have other medical uses, including for the treatment of chronic pain and anxiety disorders.

The recall information provided in the FDA notice points to Glenmark Pharmaceuticals Inc., USA, in Mahwah, NJ, was the recalling firm. Close inspection of the recall revealed some of the recalled atomoxetine bottles were manufactured for Glenmark Pharmaceuticals Inc., while others were manufactured for Northstar Rx LLC. The Glenmark Pharmaceuticals website suggests they are a global operation with “ten world‐class manufacturing facilities spread across five continents, and operations in over eighty countries.” Northstar is described on their website as “one of the few U.S.-based generic pharmaceutical providers.”

For the 10 mg capsules, two groups of products have been recalled. The first, manufactured for Glenmark Pharmaceuticals Inc., is for 70,032 bottles. The second, manufactured for Northstar Rx LLC., is for 120,000 bottles. Identifying details on this dosage of the recalled drug are:

Atomoxetine Capsules, USP, 10 milligram (mg)

• Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19232368, Exp.: 5/2025
  • 19235088, Exp.: 11/2025
  • 19241447, Exp.: 3/2026
  • 19243146, Exp.: 7/2026

• Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19232356, Exp.: 5/2025
  • 19233198, Exp.: 7/2025
  • 19234213, 19234232, Exp.: 9/2025
  • 19241445, Exp.: 3/2026
  • 19243033, 19243121, Exp.: 7/2026

For the 18 mg capsules, two groups of products have been recalled. The first, manufactured for Glenmark Pharmaceuticals Inc., is for 56,208 bottles. The second, Northstar Rx LLC., is for 119,040 bottles. Identifying details on this dosage of the recalled drug are:

Atomoxetine Capsules, USP, 18 mg

• Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19233756, Exp.: 8/2025
  • 19235111, Exp.: 11/2025
  • 19242167, Exp.: 5/2026
  • 19242180, Exp.: 5/2026

• Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19233228, 19233227, Exp.: 7/2025
  • 19233757, Exp.: 8/2025
  • 19234229, Exp.: 9/2025
  • 19235090, Exp.: 11/2025
  • 19241471, Exp.: 3/2026
  • 19242180, Exp.: 5/2026

For the 25 mg capsules, two groups of products have been recalled. The first, manufactured for Glenmark Pharmaceuticals Inc., is for 175,920 bottles. The second, manufactured for Northstar Rx LLC., is for 133,824 bottles. Identifying details on this dosage of the recalled drug are:

Atomoxetine Capsules, USP, 25 mg

• Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19233792, Exp.: 8/2025
  • 19233795, Exp.: 8/2025
  • 19234258, Exp.: 9/2025
  • 19240912, Exp.: 2/2026
  • 19241476, 19241477, Exp.: 3/2026
  • 19242599, Exp.: 6/2026
  • 19243163, 19243162, Exp.: 7/2026
  • 19243884, 19243887, Exp.:9/2026

• Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19232506, 19232397, 19232415, Exp.: 5/2025
  • 19233791, Exp.: 8/2025
  • 19234248, Exp.: 9/2025
  • 19240909, Exp.: 2/2026
  • 19242598, Exp.:6/2026
  • 19243163, 19243122, Exp.: 7/2026
  • 19243884, Exp.: 9/2026

For the 40 mg capsules, two groups of products have been recalled. The first, manufactured for Glenmark Pharmaceuticals Inc., is for 190,320 bottles. The second, manufactured for Northstar Rx LLC., is for 233,040 bottles. Identifying details on this dosage of the recalled drug are:

Atomoxetine Capsules, USP, 40 mg

• Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19234109, Exp.: 9/2025
  • 19234897, Exp.: 11/2025
  • 19240501, Exp.: 1/2026
  • 19241489, Exp.: 3/2026
  • 19241806, Exp.: 4/2026

• Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19232540, 19232524, 19232553, Exp.: 5/2025
  • 19240510, Exp.: 1/2026
  • 19241489, Exp.: 3/2026
  • 19243905, 19243935, Exp.: 9/2026

For the 60 mg capsules, two groups of products have been recalled. The first, manufactured for Glenmark Pharmaceuticals Inc., is for 80,160 bottles. The second, manufactured for Northstar Rx LLC., is for 53,952 bottles. Identifying details on this dosage of the recalled drug are:

Atomoxetine Capsules, USP, 60 mg

• Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19234630, Exp.: 10/2025
  • 19240528, 19240529, Exp.: 1/2026

• Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19234630, Exp.: 10/2025
  • 19240529, Exp.: 1/2026

For the 80 mg capsules, two groups of products have been recalled. The first, manufactured for Glenmark Pharmaceuticals Inc., is for 87,600 bottles. The second, manufactured for Northstar Rx LLC., is for 58,416 bottles. Identifying details on this dosage of the recalled drug are:

Atomoxetine Capsules, USP, 80 mg

• Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19234153, Exp.: 9/2025
  • 19234900, 19234929, Exp.: 11/2025
  • 19240936, 19240942, Exp.: 2/2026
  • 19243199, 19243190, Exp.: 7/2026
  • 19244013, 19244014, Exp.: 9/2026

• Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19233234, 19233253, Exp.: 7/2025
  • 19234154, Exp.: 9/2025
  • 19243185, Exp.: 7/2026
  • 19243951, 19243974, Exp.: 9/2026

For the 100 mg capsules, two groups of products have been recalled. The first, manufactured for Glenmark Pharmaceuticals Inc., is for 39,168 bottles. The second, manufactured for Northstar Rx LLC., is for 58,368 bottles.  Identifying details on this dosage of the recalled drug are:

Atomoxetine Capsules, USP, 100 mg

• Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30
• 30 capsule bottles,
• Lot Numbers and Expiration Dates:
  • 19234955, 19234956, Exp.: 11/2025
  • 19240971, Exp.: 2/2026
  • 19241864, Exp.: 4/2026

• Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01
• 30 capsule bottles
• Lot Numbers and Expiration Dates:
  • 19233270, 19233278, 19233285, Exp.: 7/2025
  • 19233806, Exp.: 8/2025
  • 19240954, Exp.: 2/2026
  • 19241854, Exp.: 4/2026

Contact your pharmacy or medical provider for assistance if you believe you have a bottle of the recalled medication or if you have any related questions.

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