Recall archive / FDA company announcement

Unichem Pharmaceuticals: Cyclobenzaprine Hydrochloride Tablets USP 10 mg — FDA announcement Aug 27, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Aug 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Cyclobenzaprine Hydrochloride Tablets USP 10 mg
Reason: Device & Drug Safety – Mislabel
Classification: Not supplied
Recalling firm: Unichem Pharmaceuticals
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 042ffc579ddbefa5

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – 08/27/2025– 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.; 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.

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – 08/27/2025– 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.; 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.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Aug 27, 2025
Company announcement date: Aug 27, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.