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Drug FDA Class I Ongoing Mislabeling

Cyclobenzaprine 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.

Unichem Pharmaceuticals USA Inc. Published Sep 24, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Unichem Pharmaceuticals USA Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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).

Affected products (1)

Cyclobenzaprine 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.

CYCLOBENZAPRINE HYDROCHLORIDE · 230 90-count bottles

NDC: 29300-413, 29300-414, 29300-415, 29300-413-05, 29300-413-10, 29300-413-01, 29300-413-19, 29300-414-01, 29300-414-10, 29300-415-01, 29300-415-05, 29300-415-10, 29300-415-19
Code info: Lot No: GMML24026A, Expires: 09/30/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 27, 2025
  2. Published
    Sep 24, 2025
Recall number
D-0655-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.