OTC Pain Reliever Recalled

Akron Pharma Inc is recalling numerous lots of over-the-counter acetaminophen for failing to meet tablet specifications. According to the August 24, 2022, US Food and Drug Administration (FDA) Enforcement Report, the tablets are missing an imprint.

The recall affects the following products, which were sent to 6 distributors or wholesalers who may have further distributed them:

• acetaminophen 325-mg tablets, in 100-count bottles (NDC 71399-8024-01) and 1000-count bottles (NDC 71399-8024-02), from lots AXA2001, AXA2002, AXA2003, AXA2004, AXA2005, AXA2006, AXA2007, AXA2008, AXA2009, AXA2010, AXA2011, AXA2012, AXA2013, and AXA2014 (Exp. 2/23); AKK2021, AKK30421, AKK40421, AKK50421, AKK60421, AKK70421, AKK80421, and AKK90421 (Exp. 3/24); AKL10421, AKL20421, AKL10521, AKL20521, AKL30521, AKL40521, AKL50521, AKL60521, AKL70521, AKL80521, AKL90521, and AKM10521 (Exp. 4/24); AKA10621, AKA20621, AKA30621, AKA40621, AKA50621, AKA60621, AKA70621, AKA80621, AKA90621, and AKB10621 (Exp. 5/24); and
• acetaminophen 500-mg tablets, extra strength, in 100-count bottles (NDC 71399-8022-01) and 1000-count bottles (NDC 71399-8022-02), from lots AXB2001 (Exp. 11/22); AXB2002, AXB2003, AXB2004, AXB2005, AXB2006, AXB2007, AXB2008, AXB2009, AXB2010, and AXB2011 (Exp. 12/22); and AXA2014, AXB2012, AXB2013, AXB2014, AXB2015, AXB2016, AXB2017, AXB2018, AXB2019, AXB2020, AXB2021, AXB2022, AXB2023, AXB2024, AXB2025, AXB2026, and AXB2027 (Exp. 2/23).

Akron Pharma voluntarily initiated the recall August 4, 2022. On August 17, 2022, the FDA designated the recall Class III. According to the recall classification, use of the affected tablets is not likely to cause harm.

Acetaminophen is used to treat mild to moderate pain and to reduce fever.