FDA Drugs recall ·
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0655-2025
- Date
- (initiated August 27, 2025)
- Company / brand
- Unichem Pharmaceuticals USA Inc.
1 Tower Center Blvd Ste 2200, East Brunswick, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 230 90-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot No: GMML24026A, Expires: 09/30/2027
Distribution
Nationwide within the U.S.A
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0655-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.