Urgent Recalled Issued Over Mislabeled Pain Medication

The U.S. Food and Drug Administration (FDA) has announced an urgent recall of Cyclobenzaprine Hydrochloride Tablets USP, 10 mg, after discovering that some bottles contain the wrong medication. New Jersey-based Unichem Pharmaceuticals issued the voluntary recall after bottles labeled as Cyclobenzaprine were found to contain Meloxicam 7.5 mg tablets instead. This labeling error poses a serious risk to consumers.

Meloxicam, a non-steroidal anti-inflammatory drug (NSAID), is used to treat osteoarthritis, rheumatoid arthritis, and juvenile arthritis. Consuming Meloxicam instead of Cyclobenzaprine, a muscle relaxer, can lead to potentially life-threatening side effects, especially for individuals with specific health conditions. According to the FDA, these side effects include cardiovascular issues, gastrointestinal problems, kidney damage, severe allergic reactions, and skin reactions.

The affected lot is identified by the number GMML24026A, with an expiration date of September 2027. The mislabeled tablets were distributed nationwide in 90-count bottles. Consumers who have purchased this lot are advised to stop using the medication immediately and return it to the pharmacy. Pharmacies have been instructed not to dispense bottles from this lot.

Unichem Pharmaceuticals has not received any reports of adverse events related to this recall. However, individuals who have taken the wrong medication are urged to contact their healthcare provider immediately. Adverse reactions can be reported to the FDA’s MedWatch program.