Unichem Pharma USA Recalls Mislabeled Cyclobenzaprine Tablets Nationwide

Unichem Pharmaceuticals (USA), a subsidiary of India's Unichem Laboratories, is voluntarily recalling one lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg due to mislabeling, where bottles labeled as the muscle relaxant actually contained Meloxicam 7.5 mg tablets, a non-steroidal anti-inflammatory drug used to treat arthritis. The mislabeled lot, identified as GMML24026A with an expiration date of September 2027, was distributed nationwide across the U.S. Patients unknowingly taking Meloxicam instead of Cyclobenzaprine face risks of serious adverse effects, including cardiovascular, gastrointestinal, renal complications, anaphylaxis, and skin reactions, especially if they have pre-existing conditions or are on blood thinners. No adverse events have been reported so far. Unichem is working with third-party recall provider Inmar to notify distributors, retailers, pharmacies, and consumers, urging pharmacies to stop dispensing the affected lot and consumers to return the product. The U.S. Food and Drug Administration is aware of the recall, and consumers experiencing side effects are advised to report them via the FDA MedWatch program.