Cyclobenzaprine FDA Alerts

Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling

August 27, 2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets.

Risk Statement: 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 non-steroidal anti-Inflammatory drugs and/or blood thinners, those who have allergies to the Meloxicam, or those with underlying illness. To date, Unichem Pharmaceuticals has not received any reports of adverse events related to this recall.

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.

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.

The product was distributed Nationwide to distributors, and further downstream distribution occurred to retailers and subsequently consumers.

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 with questions regarding this recall can Inmar at 1-877-840-5109 or via email a to rxrecalls@inmar.com; Monday – Friday (9 am – 5 pm; CST). 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.

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.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

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

The Product Label Subject to this recall is shown below:

Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging: Recall - Potential Mislabeling

ISSUE: Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg.

Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, which has been reported with Cyclobenzaprine HCI when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The effects of alcohol, barbiturates, and other CNS depressants may be enhanced, and may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Amantadine has a precaution in its prescribing indication about the abrupt discontinuation of the medicine. Missed doses of Amantadine in a few patients with Parkinson’s disease have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped.

BACKGROUND: Cyclobenzaprine HCl 5mg 50ct Unit Dose (NDC# 50268-190-15) is used for the relief of muscle spasms and Amantadine HCl 100mg 50ct Unit Dose (NDC# 50268-069-15) is used for the treatment of Parkinson’s and drug-induced extrapyramidal reactions and the treatment of various viral-based conditions. Both products are packaged in 50-count hospital unit dose cartons (10 unit doses per card, 5 cards per carton). The affected lot of Cyclobenzaprine and Amantadine is Lot 16710 with an expiration date of 07/2018. The subject products were fully distributed to R&S Northeast, and then further distributed nationwide.

RECOMMENDATION: Apace Packaging LLC has notified its distributors and customers by email and is arranging for return of all recalled product. Distributors that have any of the subject product which is being recalled should contact Customer Service at AvKARE, Inc. at 931-292-6222 to arrange for the return of the product.

Consumers with questions regarding this recall can contact Apace Packaging by 270-434-2722 Monday-Friday (8am – 4pm CST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/27/2017 - Press Release - Apace Packaging LLC]