D-0655-2025Class I

Unichem Pharmaceuticals USA Inc.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-09-24

Distribution

Nationwide within the U.S.A

Firm state

Product quantity

230 90-count bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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).

Product description

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.

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.