Recalls / Class I
Class ID-0655-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Cyclobenzaprine Hydrochloride
- Generic name
- Cyclobenzaprine Hydrochloride
- Active ingredient
- Cyclobenzaprine Hydrochloride
- Route
- Oral
- NDCs
- 29300-413, 29300-414, 29300-415
- FDA application
- ANDA213324
- Affected lot / code info
- Lot No: GMML24026A, Expires: 09/30/2027
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).
Recalling firm
- Firm
- Unichem Pharmaceuticals USA Inc.
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 2200, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 230 90-count bottles
- Distribution pattern
- Nationwide within the U.S.A
Timeline
- Recall initiated
- 2025-08-27
- FDA classified
- 2025-09-17
- Posted by FDA
- 2025-09-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0655-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.