NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz… was recalled on April 20, 2026 in cooperation with the U.S. Food and Drug Administration because chemical contamination; presence of lead and lithium above specification.
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Units affected: 6,336 bottles
Where it was sold: Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Chemical contamination; presence of lead and lithium above specification
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Acella Pharmaceuticals, LLC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
View official notice →The recalled sweaters violate the mandatory standard for clothing textiles, posing a risk of serious burn injuries or death.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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