FDA Issues Class I Recall of Cyclobenzaprine Tablets Due to Label Mix-Up with Meloxicam

Unichem Pharmaceuticals USA Inc. has initiated a Class I recall of cyclobenzaprine hydrochloride tablets, USP, 10 mg, packaged in 90-count bottles. The recall affects Lot No. GMML24026A, which carries an expiration date of September 30, 2027. According to the US Food and Drug Administration (FDA) Enforcement Report, the recall involves 230 bottles that were distributed nationwide in the United States. The product, manufactured by Unichem Laboratories Ltd. in Goa, India, was labeled for Unichem Pharmaceuticals’ US division based in East Brunswick, New Jersey.

The recall stems from a serious labeling mix-up in which bottles of meloxicam USP, 7.5 mg tablets (yellow in color) were mistakenly labeled as cyclobenzaprine hydrochloride USP, 10 mg tablets (blue in color). Such a mislabeling error poses a significant patient safety risk, as patients could inadvertently take the wrong medication, leading to potential adverse outcomes. Given the seriousness of the risk, the FDA classified the recall as Class I—the agency’s most urgent category, reserved for situations where use of the product may cause serious injury or death. The firm initiated the recall voluntarily and issued a nationwide press release on August 27, 2025.

For pharmacists and healthcare professionals, it is important to note that cyclobenzaprine is a prescription skeletal muscle relaxant commonly used for the short-term relief of muscle spasms associated with acute, painful musculoskeletal conditions. Patients who were dispensed the affected lot should be contacted promptly to verify their medication, and pharmacists are advised to check their inventories against the listed lot number. This recall highlights the critical importance of label accuracy in preventing harmful dispensing errors.