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
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CYCLOBENZAPRINE HYDROCHLORIDE, Unichem Pharmaceuticals USA, Inc.
- Product type
- Cyclobenzaprine Hydrochloride Tablets USP 10 mg
- Model numbers
- Lot No GMML24026A, Expires 09/30/2027
- UPC codes
- 29300-413, 29300-414, 29300-415, 29300-413-05, 29300-413-10, 29300-413-01, 29300-413-19, 29300-414-01 +5 more
- Colors
- blue, yellow
- Sizes
- 90-count bottles, 10 mg
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 27, 2025
Reported by FDA DRUG
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Cyclobenzaprine is a muscle relaxant prescribed for short-term relief of muscle spasms. Labels must correctly identify the active ingredient.
Why This Is Dangerous
The label mix-up could lead to incorrect medication administration, potential adverse drug reactions, and reduced therapeutic efficacy.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The immediate impact is confusion and potential harm if the wrong drug is taken. No injuries reported yet.
Practical Guidance
How to identify if yours is affected
- Check bottle label for Cyclobenzaprine vs Meloxicam
- Check Lot GMML24026A and expiration 09/30/2027
Where to find product info
FDA recall page and Unichem Pharmaceuticals USA, Inc. communications
What timeline to expect
Refund or replacement timelines will be provided by recall notices; typically several weeks
If the manufacturer is unresponsive
- Document all communications with the company
- Contact FDA consumer hotline if needed
- File a complaint with state board of pharmacy if necessary
How to prevent similar issues
- Always verify drug name and indication before dispensing
- Use barcode scanning when available
- Cross-check labels during packaging
Documentation advice
Keep bottle, packaging, and recall notices; note lot and expiration date
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Product Details
Product: Cyclobenzaprine Hydrochloride Tablets USP, 10 mg, 90-count bottle. Manufacturer: Unichem Laboratories Ltd, India. Manufactured for: Unichem Pharmaceuticals USA, Inc., East Brunswick, NJ. NDC 29300-415-19. Quantity: 230 bottles. Lot: GMML24026A. Expiration: 09/30/2027. Distribution: Nationwide in the USA.
Reported Incidents
No injuries or incidents have been reported in the recall notice.
Key Facts
- Lot GMML24026A
- Label mix-up between Cyclobenzaprine 10 mg and Meloxicam 7.5 mg
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Safety Guide
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