Popping an ibuprofen or aspirin tablet to dull a headache or muscle ache is a fairly regular occurrence for many people—past data from Harvard Health suggests 15% of Americans regularly take a nonsteroidal anti-inflammatory drug (commonly known as NSAIDs), which includes medications such as Aleve, Motrin, or Celebrex.

And for the nearly 20% of Americans who have arthritis, according to health experts, symptoms can include joint pain, swelling, and stiffness. Fortunately, a number of pain relievers—available over the counter or with a prescription—can help. However, one commonly prescribed option now appears to be under closer scrutiny from one U.S. agency.

On Wednesday, May 21, the U.S. Food and Drug Administration (FDA) announced to the public a nationwide recall of 9,107 bottles of Indomethacin Extended-Release Capsules. The medication appears to be available only by prescription.

According to the Cleveland Clinic, the medication works by decreasing inflammation and is often prescribed to alleviate pain, particularly when associated with arthritis. It is categorized as an NSAID, sometimes referred to by the brand name Indocin.

The reason for the recall is listed as “cGMP deviations.” Current Good Manufacturing Practice (CGMP) regulations, as reported by the FDA, exist to provide “systems that assure proper design, monitoring, and control of manufacturing processes and facilities.” However, the recall does not further specify what type of deviations were found.

The provided recall details are:

  • Indomethacin Extended-Release Capsules USP, 75 mg
  • 100-count bottle
  • Rx only
  • Lot #: 18400A
  • Expiration: 7/31/2027
  • Manufactured by: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA
  • 9,107 bottles

The manufacturer, KVK-Tech, is also listed as the recalling firm. The company’s website says they are “a leader in the development and manufacture of high-quality, FDA-approved medicines.”

The FDA has classified the recall as a Class II event, meaning the product involved may cause temporary or medically reversible adverse health effects.

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Molly Jasinski
Molly Jasinski has worked as a writer, editor and social media manager for almost 15 years. She previously worked as an editor for the magazine Birds & Blooms. She’s also held other positions at Trusted Media Brands, working on direct-to-consumer books, editing special interest publications, and assisting with digital production and social me...
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Molly Jasinski