FDA Recall D-0655-2025

Unichem Pharmaceuticals USA Inc. · East Brunswick, NJ

Class I — life-threatening Ongoing 260 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

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

Quantity: 230 90-count bottles

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).

Recall record

Recall number: D-0655-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide within the U.S.A
Recall initiated: 2025-08-27
Classified by FDA Center: 2025-09-17
FDA published: 2025-09-24
Recalling firm: Unichem Pharmaceuticals USA Inc.
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): CYCLOBENZAPRINE HYDROCHLORIDE
Generic name(s): CYCLOBENZAPRINE HYDROCHLORIDE
Manufacturer(s): Unichem Pharmaceuticals (USA), Inc.
NDC(s): 29300-413, 29300-414, 29300-415
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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