FDA alert: Mislabeled pills prompt Cyclobenzaprine recall across US; know the potential risks

A major pill mix-up has sparked a nationwide recall. Unichem Pharmaceuticals (USA), Inc. announced it is pulling back one lot of Cyclobenzaprine Hydrochloride Tablets USP, 10 mg after discovering that some bottles were mislabeled and actually contained Meloxicam 7.5 mg tablets instead.

"East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets," the US FDA has said in a press release.

That might sound like a small labeling slip, but it’s a serious deal. Meloxicam is a prescription non-steroidal anti-inflammatory drug (NSAID) used for conditions like osteoarthritis, rheumatoid arthritis, and juvenile arthritis. If someone takes it by mistake, thinking it’s Cyclobenzaprine (a muscle relaxer), the risk is high for dangerous side effects—including heart complications, stomach bleeding, kidney damage, severe allergic reactions, and skin issues. The risk is especially concerning for patients already on NSAIDs, blood thinners, or those with existing health problems.

So far, no adverse events have been reported, but the FDA and Unichem are urging patients to check their pill bottles right away.

Here’s how to spot the affected batch:

Lot number: GMML24026A

Expiration date: September 2027

NDC: 29300-415-19

Packaging: 90-count bottles

The pills themselves are a dead giveaway if you look closely.

Meloxicam 7.5 mg tablets: light yellow, flat, round with “U & L” on one side and “7.5” on the other.

Cyclobenzaprine 10 mg tablets: blue, round, film-coated with “U” on one side and “12” on the other.

If you’ve got Cyclobenzaprine in your medicine cabinet, double-check your bottle. If it matches the recalled lot, don’t take it, contact your pharmacist or healthcare provider immediately.