When you wake up with the throbbing pain of a migraine or the ache of arthritis, you probably head straight to a bathroom or kitchen cabinet to grab some medicine, crossing your fingers that it’ll kick in quickly.

But that discomfort won’t be going anywhere if the medicine bottle contains a totally different drug than the one on the label, a possibility the U.S. Food and Drug Administration (FDA) is now warning the public about for one particular type of prescription.

Late last week, the FDA alerted consumers about a recall of 2,946 bottles for 500-count Celecoxib, saying the recall is both nationwide in the U.S. and in Puerto Rico. According to the agency’s report, the recall is due to a “product mix-up.” It states, “Customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule.”

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that is often used to treat “mild to moderate pain and help relieve symptoms of arthritis,” the Mayo Clinic explains. It’s also commonly used to treat migraines (without or with aura), menstrual cramps, acute pain, and other health conditions. It also goes by the brand names of CeleBREX and Elyxyb.

Tadalafil, on the other hand, is a medication used to treat erectile dysfunction, and is sold under brand names like Adcirca, ALYQ, and Cialis, according to the Cleveland Clinic.

The FDA notice indicates that Celecoxib is available by prescription only.

It also shared the following details about the product:

  • Product: Celecoxib Capsules, 200 mg, 500-count bottle, Rx Only
  • Batch 2405014780
  • Expiration Date: Sep. 30, 2027
  • Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Gujarat, India
  • Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ
  • National Drug Code (NDC): 62332-142-71
  • 2,946 total bottles

The FDA report suggests that Alembic Pharmaceuticals Limited initiated the recall on May 9. Alembic Pharmaceuticals is an India-based pharmaceutical company and is part of one of “India’s oldest industrial houses” in healthcare, according to its website.

The FDA, however, announced that the recall is being considered a Class II risk on June 6. Class II recalls involve products “that may cause temporary or medically reversible adverse health effects.”

This isn’t the first recall from this particular pharmaceutical company that we’ve seen in recently. Just a few weeks ago, we reported on the nationwide recall of Alembic Pharmaceuticals-manufactured eye drops.

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Emily Surpless
Emily has over a decade of experience producing digital content, working on sites focused on health, lifestyle, home, and entertainment. As the editor for The Healthy by Reader’s Digest, she focuses on pitching and optimizing content to satisfy reader curiosity and reach new users. Prior to her role at The Healthy, Emily was the Sr. SEO Manager ...
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Emily Surpless