The Recall Desk
CriticalFDA (Drugs)·D-0655-2025·Announced 2025-09-24

Cyclobenzaprine bottles recalled after being filled with meloxicam tablets instead

Unichem Cyclobenzaprine Hydrochloride Tablets, 10 mg, lot GMML24026A, are recalled because bottles labeled as cyclobenzaprine contained yellow Meloxicam 7.5 mg tablets. The FDA classified the action as Class I.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this label mix-up as Class I.

Plain-English summary

Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, in 90-count bottles and available on prescription only, manufactured by Unichem Laboratories, Ltd in Goa, India for Unichem Pharmaceuticals (USA), Inc. of East Brunswick, New Jersey, are being recalled. The affected product is lot GMML24026A, expiring 09/30/2027, and the recall covers 230 90-count bottles distributed nationwide.

The recall was issued because of a label mix-up: bottles of Meloxicam USP 7.5 mg 90-count tablets, which are yellow, were labeled as Cyclobenzaprine Hydrochloride Tablets USP 10 mg 90-count tablets, which are blue. The FDA classified the action as Class I, its most serious category.

Patients should check the lot number on their bottle and the appearance of the tablets, and should contact their pharmacist before taking any tablet that does not match the expected description.

The recalled product

Product
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
Brand
CYCLOBENZAPRINE HYDROCHLORIDE
Manufacturer
Unichem Pharmaceuticals USA Inc.
Hazard
  • label-mixup
  • wrong-drug
  • prescription-drug
  • class-i

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot No: GMML24026A
  • Expires: 09/30/2027

Distribution

Distributed nationwide across the United States.