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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cyclobenzaprine Tablets Recalled Due to Label Mix-Up with Meloxicam

Agency Publication Date: September 17, 2025
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Summary

Unichem Pharmaceuticals USA Inc. is recalling 230 bottles of Cyclobenzaprine Hydrochloride Tablets (10 mg) because some bottles may actually contain Meloxicam (7.5 mg). Cyclobenzaprine is a muscle relaxant that is typically a blue tablet, but the mislabeled bottles may contain yellow Meloxicam tablets, which is a non-steroidal anti-inflammatory drug (NSAID). No incidents or injuries have been reported to date, but this mix-up could lead to consumers taking the wrong medication.

Risk

Taking Meloxicam when expecting Cyclobenzaprine can lead to unintended NSAID exposure, which may cause serious risks including gastrointestinal bleeding, kidney issues, or allergic reactions, especially in patients already taking other NSAIDs or with pre-existing conditions.

What You Should Do

  1. Check your prescription bottle for Cyclobenzaprine Hydrochloride Tablets, 10 mg (NDC 29300-415-19) with lot number GMML24026A and an expiration date of 09/30/2027.
  2. Inspect the tablets inside the bottle: if the tablets are yellow instead of the expected blue color, you may have the mislabeled medication.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
🗑️Option 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cyclobenzaprine Hydrochloride Tablets, USP (90-count bottle)
Variants: 10 mg, Tablet
Lot Numbers:
GMML24026A (Exp 09/30/2027)
NDC:
29300-415-19

Mislabeled; bottles may contain yellow Meloxicam USP 7.5mg tablets instead of blue Cyclobenzaprine tablets.

Product Images

Cyclobenzaprine Hydrochloride Tablets, USP 10 mg package front”

Cyclobenzaprine Hydrochloride Tablets, USP 10 mg package front”

“Inside package label”

“Inside package label”

Meloxicam 7.5mg Tablet

Meloxicam 7.5mg Tablet

Cyclobenzaprine HCl, 10mg Tablet

Cyclobenzaprine HCl, 10mg Tablet

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97482
Status: Active
Manufacturer: Unichem Pharmaceuticals USA Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 230 90-count bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.