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Recall Observatory FDA recall evidence

Drug product

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.

D-0655-2025

August 27, 2025

Class I

Product summary

Firm
Unichem Pharmaceuticals USA Inc.
Event
Event 97482
Status
Ongoing
Classification
Class I
Quantity
230 90-count bottles
Official record key
drug-enforcement:D-0655-2025

Official wording

Reason: 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).

Code information: Lot No: GMML24026A, Expires: 09/30/2027

Distribution pattern: Nationwide within the U.S.A

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix Up