Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, L
Summary
The FDA issued a Class I for Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, by Unichem Pharmaceuticals USA Inc.. Reason: Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP.
Details
Source
Drug Recall
External ID
D-0655-2025
Action Date
2025-09-24
Status
Ongoing
Category
drug
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/Code Info: Lot No: GMML24026A, Expires: 09/30/2027
Quantity Affected: 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).
Distribution
Nationwide within the U.S.A
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-27
Company
East Brunswick, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 68 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Unichem Pharmaceuticals USA Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Unichem Pharmaceuticals USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Unichem Pharmaceuticals USA Inc. have FDA actions?
Unichem Pharmaceuticals USA Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0655-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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