Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: ...
FDA Recall #D-0655-2025 — Class I — August 27, 2025
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.
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).
Recalling Firm
Unichem Pharmaceuticals USA Inc. — East Brunswick, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
230 90-count bottles
Distribution
Nationwide within the U.S.A
Code Information
Lot No: GMML24026A, Expires: 09/30/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated