HIGH

Unichem Pharmaceuticals Recalls Cyclobenzaprine Tablets Due to Labeling Error

Unichem Pharmaceuticals recalled 230 bottles of Cyclobenzaprine Hydrochloride Tablets on August 27, 2025. The recall stems from a labeling mix-up with Meloxicam tablets, which could lead to serious health risks. Consumers should stop using the product immediately and contact their healthcare provider.

Quick Facts at a Glance

Recall Date
August 27, 2025
Hazard Level
HIGH
Brands
CYCLOBENZAPRINE HYDROCHLORIDE, Unichem Pharmaceuticals (USA), Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Unichem Pharmaceuticals USA Inc. or your healthcare provider for guidance. Notification method: Press Release

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Product Details

The recalled product is Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, in 90-count bottles. It was manufactured by Unichem Laboratories, Ltd. and distributed nationwide in the USA.

The Hazard

The recall was initiated due to a labeling error that mixed up Cyclobenzaprine Hydrochloride Tablets with Meloxicam USP, 7.5 mg tablets. This mix-up poses a risk of patients receiving the wrong medication, which could lead to adverse health effects.

Reported Incidents

As of the recall date, no injuries have been reported. However, the potential for misuse of the medication due to labeling confusion remains a serious concern.

What to Do

Consumers should stop using the recalled tablets immediately. Contact Unichem Pharmaceuticals USA Inc. or your healthcare provider for further guidance and information on returning the product.

Contact Information

For further assistance, consumers can reach Unichem Pharmaceuticals at their official website or by calling customer service.

Key Facts

  • Recalled product: Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg
  • Labeling error involved Meloxicam tablets
  • 230 bottles recalled nationwide
  • Stop using the product immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCyclobenzaprine Hydrochloride Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot No: GMML24026A
Expires: 09/30/2027
UPC Codes
29300-413
29300-414
29300-415
+10 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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