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Lower risk Drug recall · FDA · Published August 27, 2025

Unichem Cyclobenzaprine Tablets Recalled Due to Label Mix-Up

Unichem Pharmaceuticals USA recalls 10mg Cyclobenzaprine tablets due to mislabeled with Meloxicam. Affected products have yellow bottles labeled as blue. Contact for details.

🇺🇸 FDA recall #D-0655-2025DrugUnichem ›
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Recalling firmUnichem Pharmaceuticals USA Inc.1 Tower Center Blvd Ste 2200 · East Brunswick, NJ 08816-1145
✎ GovInfoNow plain-language explainer

What happened, in plain English

Unichem Pharmaceuticals USA is recalling 10mg Cyclobenzaprine Hydrochloride Tablets that were mislabeled as Meloxicam. This mix-up could lead to incorrect medication use if taken by mistake. Read more at govinfonow.com/recall/31847-unichem-cyclobenzaprine-tablets-recalled-due-to-label-mix-up.

Source Summary by GovInfoNow · govinfonow.com/recall/31847-unichem-cyclobenzaprine-tablets-recalled-due-to-label-mix-up · Updated August 17, 2026 · FDA enforcement record: FDA #D-0655-2025

Cite this page

“Unichem Cyclobenzaprine Tablets Recalled Due to Label Mix-Up.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31847-unichem-cyclobenzaprine-tablets-recalled-due-to-label-mix-up. Based on FDA recall #D-0655-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2025%22&limit=1).

Why it’s dangerous

The product was labeled incorrectly as Cyclobenzaprine when it is actually Meloxicam. This mix-up could cause someone to take the wrong medication if they mistake the labels.

Who’s affected

Prescription users of Cyclobenzaprine tablets who received the mislabeled product. Those with Meloxicam prescriptions are at higher risk due to potential confusion.

How to tell if you have this one

Check for yellow bottles labeled as blue Cyclobenzaprine tablets. The product was sold with NDC 29300-415-19 and lot number GMML24026A.

  • Brand
    Unichem
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for yellow bottles labeled as blue Cyclobenzaprine Hydrochloride Tablets USP 10 mg.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the U.S.A” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 28 days after the firm started it.

1. Firm started the recall: Aug 27, 202512. FDA classified it Class I: Sep 17, 202523. Published in FDA’s Enforcement Report: Sep 24, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product dangerous if taken?

The recall is for mislabeling, not a safety hazard. Taking the product as labeled could cause incorrect medication use.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0655-2025 (August 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0655-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA