More Than 200,000 Containers of a Trusted Anxiety Medication Recalled Nationwide and in Puerto Rico

Whereas it was long taboo in our society to vocally address mental health, the increased rates of reported symptoms are now being better reframed as an only-natural response to the times we’re living in. In 2020, national data suggested more than 16% of Americans had taken prescription medications to care for their mental health—and that was at the very beginning of the widespread emotional upheaval brought on by the pandemic, and before the current presidential administration’s February 13 announcement that strategized to “assess the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, stimulants,” and other drugs to manage mood.

If your medication is on your mind, Thursday the U.S. Food and Drug Administration released a report that a frequently prescribed anxiety drug is now facing a recall. On February 19, the FDA announced the recall has been categorized as a Class II event, which “involves products that may cause temporary or medically reversible adverse health effects.”

The original recall was executed in January for 204,155 total cartons of lorazepam by the Harvard Drug Group LLC, doing business as Major Pharmaceuticals and Rugby Laboratories based in La Vergne, TN. The Major Pharmaceuticals and Rugby Laboratories website suggests the company is “one of the largest, multi-source suppliers of generic Rx and OTC products.” The FDA states that the recall affects product distributed “nationwide U.S. and Puerto Rico.”

The recall reasoning is listed as “Failed impurities/degradation specifications and Sub-potent Drug,” which could signal the recalled tablets contain defects or were not formulated to the correct strength for the indicated dosage. The FDA’s report further explains that routine stability testing for assay (testing for ingredients and composition) and impurities resulted in “out-of-specification results.”

The recall includes a total of 204,155 cartons of three lorazepam dosages: 0.5 milligram (mg), 1 mg, and 2 mg. For all, the FDA names Major Pharmaceuticals, in Indianapolis, IN, as the packager and distributor of the recalled tablets.

For the 0.5 mg tablets, 82,281 cartons have been recalled. Identifying details on this dosage of the recalled drug are:

Lorazepam Tablets, USP, 0.5 mg, Unit Dose

• 100 tablets per carton (10 x 10 blister packs)
• Lot Numbers and Expiration Dates:
  • N01424, N01425, Exp 03/31/2025
  • N01659, N01660, Exp 08/31/2025
  • N01668, 09/2025
  • N01679, N01704, N01745, Exp 10/31/2025
  • N01856, Exp 02/28/2026
  • N01973, Exp 05/31/2026
  • N02079, Exp 08/31/2026

For the 1 mg tablets, 94,349 total cartons have been recalled:

Lorazepam Tablets, USP, 1 mg, Unit Dose

• 100 tablets per carton (10 x 10 blister packs)
• Lot Numbers and Expiration Dates:
  • N01419, N01420, N01421, Exp 03/31/2025
  • N01663, Exp 06/30/2025
  • N01664, Exp 08/31/2025
  • N01673, Exp 09/30/2025
  • N01688, Exp 08/31/2025
  • N01747, N01748, N01749, Exp 11/30/2025
  • N01792, Exp 12/31/2025
  • N01857, Exp 02/28/2026
  • N01974, Exp 05/31/2026
  • N02081, Exp 08/31/2026

For the 2 mg tablets, 27,525 total cartons have been recalled:

Lorazepam Tablets, USP, 2 mg, Unit Dose

• 100 tablets per carton (10 x 10 blister packs)
• Lot Numbers and Expiration Dates:
  • N01422, N01423, Exp 03/31/2025
  • N01661, N01662, Exp 09/30/2025
  • N01746, N01750, Exp 10/31/2025
  • N01876, N01877, Exp 03/31/2026
  • N01899, N01900, N01975, Exp 04/30/2026

Lorazepam, which is only available via a prescription, is often used to treat individuals experiencing anxiety, insomnia, or seizures, according to the National Alliance of Mental Illness (NAMI). Lorazepam may go by a brand name such as Ativan and is part of the benzodiazepines (sometimes commonly referred to as benzos) class of medication—Xanax, Klonopin, and Valium are brand names of other examples of benzodiazepines. The Cleveland Clinic says drugs like lorazepam are “tightly regulated” and are administered with the intent to “slow down activity in your brain and nervous system.”

If you believe you have the affected drugs in your possession, contact your pharmacy or medical provider for assistance.

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