Class IOngoing

Cyclobenzaprine Hydrochloride Tablets recall

FDA recall D-0655-2025 · initiated Aug 27, 2025

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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).

Details

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.
Recalling company: Unichem Labs Ltd
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the U.S.A
Initiated: Aug 27, 2025
FDA report date: Sep 24, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0655-2025 ↗

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