Pain medication sold at Walmart in at least 41 states is being recalled across the country due to a manufacturing error that could have "fatal" consequences, the FDA warns.
A Pain Medication Has Been Recalled Nationwide
Published on Feb. 05, 2025
When fentanyl makes the news, it’s usually for the heavy toll it’s taken on our nation as a deadly street drug. In fact, the synthetic opioid, which is up to 50 times stronger than heroin and 100 times stronger than morphine, causes over 150 overdose deaths in America each day, according to a fentanyl fact sheet published by the Centers for Disease Control and Prevention (CDC).
Despite the apparent dangers of fentanyl, the drug is still sometimes prescribed to patients experiencing severe and persistent pain. Now, a new recall illustrates how the pain medication can pose a serious threat, even in controlled clinical settings.
According to an announcement from the U.S. Food and Drug Administration (FDA) on January 31, 2025, the pharmaceutical company Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The patches were distributed nationwide, including at major pharmacies such as Walmart. The full list of Walmart locations in 41 states where the chain says the product was distributed is available via Walmart’s recall page.
“The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch,” the recall notice explains, describing the error as a defective delivery system. This means there’s a risk of patients administering significantly more than one dose without being aware that there were multiple patches stuck together in the pouch—as the FDA explains: “There is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life threatening, or fatal respiratory depression.”
At the time of the recall, the company had received one report of serious adverse effects resulting from use of the product. The FDA notes that children, the elderly, and people using the patches for the first time could be at increased risk of complications. The product is approved for use in opioid-tolerant patients for whom alternative treatment options are determined to be ineffective.
The product is packaged in cartons of five individually wrapped and labeled pouches. You may recognize the affected cartons using the following identifying information:
- Dose: 25 mcg/h
- Lot number: 108319
- Expiration date: April 2027
If you have been prescribed this medication and currently have a patch in use, remove it immediately, follow the FDA’s instructions to dispose of it safely, and contact your health care provider. Return any unused products to your place of purchase to request a replacement.
Consumers can direct their questions regarding this recall to Alvogen Customer Complaints by calling 866-770-3024 or by emailing alvogensmb [at] continuumindia.com.
You can also report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
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