A-S Medication Solutions, LLM has voluntarily recalled nearly 200,000 bottles of extra-strength acetaminophen 500mg tablets due to a mislabeling issue. According to the Food and Drug Administration (FDA), the bottles have “an incomplete prescription drug label rather than the required OTC Drug Facts label.” 

If the safety warnings on the OTC label are not considered, acetaminophen could be potentially harmful. The correct label includes warnings about liver damage if the recommended dose is exceeded; if users combine with excessive consumption of alcohol; or if consumers are allergic to the active ingredient. 

Humana included the 100-count bottles as part of Health Essentials Kits for its members. The impacted bottles were likely distributed nationwide between January 14, 2021, and March 15, 2021, with expiration dates of either July 31, 2022, or August 31, 2022.

So far, there have been no reports of adverse events concerning the recalled product. However, the FDA is requesting that all affected bottles be returned.