FDAHealthAugust 27, 2025

Unichem Pharmaceuticals USA Inc. — Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa

⚠️ 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).

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: August 27, 2025

Nationwide within the U.S.A

What's affected?

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.
Brand: CYCLOBENZAPRINE HYDROCHLORIDE
Lot code: No:

Additional details

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

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 230 90-count bottles.

View original FDA notice →

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