Mislabeling Leads to Cyclobenzaprine Hydrochloride Recall

FDA announced on Aug. 27, 2025 that Unichem Pharmaceuticals (USA) has voluntarily recalled one lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg. The recall was initiated because the Cyclobenzaprin label was placed on a bottle that contained Meloxicam 7.5 mg tablets.

While the company has not received any reports of adverse events as of the date of the recall notice, if Meloxicam is taken unknowingly, serious events could result, such as cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions. This is especially the case for patients taking concomitant non-steroidal anti-inflammatory drugs (NSAIDs) or blood thinners.

Two very different products

Cyclobenzaprine Hydrochloride Tablets USP 10 mg is used as a muscle relaxer and as an add-on treatment to physical therapy to relieve muscle spasms that result from acute musculoskeletal conditions.Meloxicam Tablets USP, 7.5 mg, however, is a NSAID used for osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.

Customers can tell the difference between the two drugs by their description. Cyclobenzaprine Hydrochloride Tablets USP 10 mg are round, biconvex tablets that are blue in color and film coated, with a “U” debossed on one side and “12” debossed on the other side. Meloxicam Tablets USP, 7.5 mg is a light yellow, round, flat beveled-edged tablet that has “U & L” debossed on one side and “7.5” debossed on the center of the other side.

Details on the recalled lot

The recalled lot is lot number GMML24026A, has an expiry date of Sept 2027, and NDC 29300-415-19 printed on the label of the 90-count bottles. It was distributed nationwide to distributers and downstream to retailers and consumers.

The recall is being conducted by a third-party provider, Inmar, which is notifying distributors, retailers, and consumers and arranging for return of the recalled product. “Our downstream trading partners that have Cyclobenzaprine Hydrochloride Tablets USP, 10mg with Lot# GMML24026A, Exp Sept 2027, which is being recalled, should not further distribute this medication, and notify their customers accordingly. Retail pharmacies should not dispense from this lot number, GMML24026A, and call the number provided for guidance on how to return this drug product. Any pharmacy who has dispensed this lot of Cyclobenzaprine, should notify the consumer. Consumers should return the medication to the pharmacy they received their prescription from,” the company stated in a press release (1).

Adverse events can be reported to FDA via the agency’s MedWatch Adverse Event Reporting program. www.fda.gov/medwatch/report.htm

What causes these types of recalls?

Regulatory agencies inspect manufacturing facilities to, in part, to prevent these types of recalls, which can be caused by human error or a lack of good manufacturing practice procedures. The agency will often issue form 483 and/or a warning letter to drug manufacturers to advise them of changes needed to their procedures or facilities so that recalls can be avoided.

In an article published in PharmTech Group’s Quality and Regulations 2025 eBook, experts from Sia/LBG review some of the most common findings from FDA 483s and suggest strategies for preventing regulatory non-compliance.

“Issuance of an FDA Form 483 or a warning letter could be regarded in some way as a potential barometer of regulatory performance, but if a company acts responsibly and thoroughly, they can resolve the concerns quickly and professionally to minimize potential impacts and maintain and improve compliance over time,” the authors state (2).

References

1. FDA. Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling. Press Release. Aug. 27, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unichem-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-cyclobenzaprine-hydrochloride
2. Falvey, P.; Sloboda, G.; DeDonder, S.;Schoukroun-Barnes, L. New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s. Pharmaceutical Technology® Quality and Regulations eBook 2025, August. https://www.pharmtech.com/view/new-year-same-challenges-pharma-s-ongoing-struggle-with-fda-483s