Unichem Pharma USA recalls one lot of Cyclobenzaprine Hydrochloride Tablets 10 mg over mislabeling

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-09-03T13:33:44+05:30 | Updated On 3 Sept 2025 1:33 PM IST

East Brunswick: Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level in U.S. due to mislabeling. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets.

To date, Unichem Pharmaceuticals has not received any reports of adverse events related to this recall.

For patients who unknowingly take Meloxicam there is a reasonable probability of serious adverse events including cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions, particularly in those patients taking concomitant nonsteroidal anti-Inflammatory drugs and/or blood thinners, those who have allergies to the Meloxicam, or those with underlying illness.

Meloxicam Tablets USP, 7.5 mg is a non-steroidal anti-inflammatory drug, indicated for use in Osteoarthritis, Rheumatoid Arthritis, and Juvenile Rheumatoid Arthritis.

Meloxicam Tablets, USP, 7.5 mg is light yellow, round flat beveled edged, tablet with “U & L” debossed on one side and “7.5” debossed centrally on the other side.

Cyclobenzaprine Hydrochloride Tablets USP, 10mg is a muscle relaxer and indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, are blue colored, film coated, round shaped, biconvex tablets, debossed with “U” on one side and “12” debossed on other side.

According to the release, the mislabeled bottles of Cyclobenzaprine Hydrochloride Tablets USP, 10mg but containing Meloxicam 7.5mg tablets, can be identified by the lot number GMML24026A and expiry of Sept 2027 and NDC 29300-415-19 printed on the label of the 90-count bottles.

"Unichem Pharmaceuticals (USA), Inc. is notifying its downstream trading partners, their retailers and consumers of the recall through our third party recall provider, Inmar. Inmar is arranging for the return of the subject recalled Cyclobenzaprine Hydrochloride Tablets USP, 10mg labeled with Lot # GMML24026A. 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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product," the release stated.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

unichem pharmacyclobenzaprine hydrochloride tabletsmeloxicam tabletsosteoarthritisrheumatoid arthritisjuvenile rheumatoid arthritis

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751