Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot No: GMML24026A, Expires: 09/30/2027
Where it was sold
Nationwide within the U.S.A
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0655-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 27, 2025
- FDA report date
- Sep 24, 2025
- Quantity
- 230 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0655-2025, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97482
- Address
- 1 Tower Center Blvd Ste 2200
- Code information
- Lot No: GMML24026A, Expires: 09/30/2027
- Postal code
- 08816-1145
- Report date
- Sep 24, 2025
- Product type
- Drugs
- Recall number
- D-0655-2025
- Classification
- Class I
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
- Product 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the U.S.A
- Recall initiation date
- Aug 27, 2025
- Initial firm notification
- Press Release
- Center classification date
- Sep 17, 2025