Class I
Ongoing
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.
This recall is currently active, issued September 24, 2025. It was issued by Unichem Pharmaceuticals Usa Inc..
- Company
- Unichem Pharmaceuticals Usa Inc.
- Recall Initiated
- August 27, 2025
- Posted
- September 24, 2025
- Recall Number
- D-0655-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 230 90-count bottles
- Firm Location
- East Brunswick, NJ, United States
- Official Source
- View on FDA website ↗
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).
Distribution
Nationwide within the U.S.A
Lot / Code Info
Lot No: GMML24026A, Expires: 09/30/2027
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