{"id":99014,"date":"2025-08-28T16:16:09","date_gmt":"2025-08-28T16:16:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/uk\/99014\/"},"modified":"2025-08-28T16:16:09","modified_gmt":"2025-08-28T16:16:09","slug":"fda-issues-urgent-recall-over-mislabeled-pain-killers-reasonable-probability-of-life-threatening-reaction","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/uk\/99014\/","title":{"rendered":"FDA issues urgent recall over mislabeled pain killers… ‘reasonable probability’ of life-threatening reaction"},"content":{"rendered":"

By ALEXA LARDIERI, US DEPUTY HEALTH EDITOR<\/a> <\/p>\n

Published: 10:56 EDT, 28 August 2025 | Updated: 10:57 EDT, 28 August 2025 <\/p>\n

An urgent recall<\/a> has been issued for medication that’s been mislabeled, leading the FDA<\/a> to warn that some Americans could suffer life-threatening reactions if they consume the incorrect pills.\u00a0<\/p>\n

New Jersey-based Unichem Pharmaceuticals is voluntarily recalling one lot of\u00a0Cyclobenzaprine Hydrochloride Tablets USP in 10 mg pills.\u00a0\u00a0<\/p>\n

A label of Cyclobenzaprine 10mg (90ct) was incorrectly placed on a bottle containing Meloxicam 7.5 mg tablets.\u00a0<\/p>\n

Cyclobenzaprine, common brands Fexmid and Amrix, is a prescription-only muscle relaxant to treat muscle spasms. It is typically only used for two to three weeks at a time.\u00a0<\/p>\n

Meloxicam, common brands Mobic and Vivlodex, is a prescription\u00a0nonsteroidal anti-inflammatory drug (NSAID) used to treat pain, inflammation, and stiffness associated with various types of arthritis.<\/p>\n

The FDA said in its recall notice: ‘For patients who unknowingly take Meloxicam there is a reasonable probability of serious adverse events<\/a> including cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions.’<\/p>\n

Reactions can occur particularly in people who regularly take other NSAIDs for certain medical conditions, or in people who are allergic to Meloxicam and have certain comorbidities.\u00a0<\/p>\n

\"Pictured <\/p>\n

Pictured above are\u00a0Meloxicam tablets. In the recent recall, a label for\u00a0Cyclobenzaprine was mistakenly placed on a bottle containing Meloxicam pills<\/p>\n

\"Pictured <\/p>\n

Pictured above are Cyclobenzaprine Hydrochloride tablets.\u00a0In the recent recall, a label for Cyclobenzaprine was mistakenly placed on a bottle containing Meloxicam pills<\/p>\n

There have been no adverse events reported to date related to this recall.\u00a0<\/p>\n

Meloxicam is used in people with osteoarthritis, rheumatoid arthritis and juvenile rheumatoid arthritis. These conditions are suffered by approximately 34.3 million Americans combined.<\/p>\n

According to some estimates, there are about 20.7million prescriptions written for the drug for nearly 7million patients in the US per year.\u00a0<\/p>\n

Meloxicam tablets are round, light yellow and have ‘U & L’ engraved on one side and ‘7.5’ engraved on the other side.<\/p>\n

Meanwhile,\u00a0Cyclobenzaprine Hydrochloride tablets USP\u00a0are round, blue, film coated and engraved with ‘U’ on one side and ’12’ on other side.<\/p>\n

About 24million prescriptions were written for the drug in 2024. They are used as short-term pain and soreness treatment for discomfort caused by muscle spasms.\u00a0<\/p>\n

The mislabeled bottles of Cyclobenzaprine Hydrochloride can be identified by their lot number:\u00a0GMML24026A.<\/p>\n

They have an expiration date of September 2027 and NDC 29300-415-19 is printed on the label of the 90-count bottles.<\/p>\n

\"The <\/p>\n

The above shows a label for\u00a0Cyclobenzaprine Hydrochloride tablets<\/p>\n

\"The <\/p>\n

The above shows a label for Cyclobenzaprine Hydrochloride tablets<\/p>\n

The pills were distributed nationwide to distributors and furthermore to retailers and consumers.\u00a0<\/p>\n

The company is advising any location with the mislabeled bottles to stop distributing the medication and notify customers of the mistake.\u00a0<\/p>\n

Additionally, retail pharmacies should not dispense the medication and contact Inmar, the company arranging for the return of the recalled product, for further instructions.\u00a0<\/p>\n

The pharmacies should also contact and notify customers, who should then return the mislabeled medication to the place of purchase.\u00a0\u00a0<\/p>\n

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\n FDA issues urgent recall over mislabeled pain killers… ‘reasonable probability’ of life-threatening reaction<\/p>\n","protected":false},"excerpt":{"rendered":"By ALEXA LARDIERI, US DEPUTY HEALTH EDITOR Published: 10:56 EDT, 28 August 2025 | Updated: 10:57 EDT, 28…\n","protected":false},"author":2,"featured_media":99015,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[97,102,6591,56,54,55],"class_list":{"0":"post-99014","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-dailymail","9":"tag-health","10":"tag-medication","11":"tag-uk","12":"tag-united-kingdom","13":"tag-unitedkingdom"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/99014","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=99014"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/99014\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/99015"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=99014"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=99014"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=99014"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}