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Class I · Most seriousActive recall

Cyclobenzaprine Hydrochloride

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot No: GMML24026A, Expires: 09/30/2027
Where it was soldNationwide within the U.S.A
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byUnichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ foreign manufacturer
Brand nameCYCLOBENZAPRINE HYDROCHLORIDE
Generic nameCYCLOBENZAPRINE HYDROCHLORIDE
Active ingredient(s)CYCLOBENZAPRINE HYDROCHLORIDE
Distributed by / forUnichem Pharmaceuticals (USA), Inc. East Brunswick, NJ
NDC29300-415-19
Show the full FDA record
Full product labelCyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Recalling firmUnichem Pharmaceuticals USA Inc.
DistributionNationwide within the U.S.A
Quantity230 90-count bottles
Recall initiated2025-08-27
Report date2025-09-24
Recall completed—
Recall numberD-0655-2025
ClassificationClass I
FDA statusOngoing
Origin on fileEast Brunswick NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.