Unichem Pharmaceuticals (USA) Inc., a wholly owned subsidiary of Unichem Laboratories, has announced a voluntary nationwide recall of one lot of Cyclobenzaprine Hydrochloride Tablets USP, 10 mg in the United States due to mislabeling issues.
According to the company’s filing, bottles labeled as Cyclobenzaprine 10 mg (commonly prescribed as a muscle relaxant) were found to actually contain Meloxicam 7.5 mg tablets, a non-steroidal anti-inflammatory drug (NSAID) used in conditions like osteoarthritis and rheumatoid arthritis.
Risk statement
The company warned that patients unknowingly consuming Meloxicam could face serious adverse events, including cardiovascular, gastrointestinal, renal complications, anaphylaxis, or skin reactions—especially for those already on NSAIDs, blood thinners, or with pre-existing conditions. However, no adverse events have been reported so far.
Recall details
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Affected Lot: GMML24026A
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Expiry: September 2027
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NDC: 29300-415-19
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Pack Size: 90-count bottles
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Distribution: Nationwide in the US through distributors, retailers, and pharmacies.
Unichem confirmed it has engaged third-party recall provider Inmar to manage returns and notify downstream partners. Pharmacies holding the affected lot have been asked to stop distribution immediately and inform customers. Consumers are advised to return the product to their dispensing pharmacy.
FDA involvement
The recall is being conducted with the knowledge of the US Food and Drug Administration (FDA). Consumers experiencing side effects are urged to report through the FDA’s MedWatch program.
This incident underscores the importance of strict quality checks in pharmaceutical packaging and labeling, given the significant risks of mislabeling in prescription medications.
