Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

314 recalls in this category, newest first.

Class III · Low risk

CVS Pharmacy

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Terminated Wrong potency / content Ohm Laboratories, Inc. D-0023-2016
Class I · High risk

Mucinex Fast Max Night Time Cold & Flu

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

Terminated Labeling / mix-up Reckitt Benckiser LLC NDC 63824-500-66 D-1364-2015
Class III · Low risk

Cetirizine HCl Chewable Tablet

Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

Terminated Impurity / degradation Sandoz, Inc NDC 66394-041-06 D-1115-2015
Class III · Low risk

Fexofenadine Hydrochloride Tablets

Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing

Terminated Impurity / degradation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-547-20 D-1083-2015
Class III · Low risk

Fexofenadine HCl Tablets

Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Terminated Impurity / degradation Mylan Pharmaceuticals Inc. NDC 0378-0781-91 D-0435-2015