FDAFDA · Food and drugs·Recall number D-0655-2025
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.
Published September 24, 2025 · Recall initiated: August 27, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- CYCLOBENZAPRINE HYDROCHLORIDE
- Manufacturer
- Unichem Pharmaceuticals USA Inc.
- Distributor
- Nationwide within the U.S.A
- Lot
- Lot No: GMML24026A, Expires: 09/30/2027
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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