Unichem Pharmaceuticals USA Inc. drug recall: Cyclobenzaprine Hydrochloride Tablets
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97482
- Recall initiated
- Aug 27, 2025
- Classified by FDA
- Sep 17, 2025
- Posted in Enforcement Report
- Sep 24, 2025
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
- Firm location
- East Brunswick, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Press Release
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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).
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 27, 2025. FDA classified it 21 days later, on Sep 17, 2025. Distribution reported by FDA: Nationwide within the U.S.A Unichem Pharmaceuticals USA Inc. has 12 recalls in our records.
Recalled products (1)
D-0655-2025 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.
Codes / lots: Lot No: GMML24026A, Expires: 09/30/2027
Quantity: 230 90-count bottles
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 97482
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.