Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

Is Fexofenadine recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Fexofenadine (89 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Fexofenadine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Fexofenadine recalls on record

none so far in 2026; 89 on record, newest first
Class II · Moderate risk

Allergy Relief

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation Aurolife Pharma, LLC NDC 46122-387-23 D-1866-2019
Class II · Moderate risk

Allergy Relief

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation Aurolife Pharma, LLC NDC 60000-409-53 D-1865-2019
Class II · Moderate risk

Allergy Relief D

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Terminated Impurity / degradation Sun Pharmaceutical Industries, Inc. D-1388-2019
Class II · Moderate risk

Allergy Relief D

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Terminated Impurity / degradation Sun Pharmaceutical Industries, Inc. D-1387-2019
Class II · Moderate risk

Fexofenadine HCl Tablets

Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.

Terminated Impurity / degradation Mylan Pharmaceuticals Inc. NDC 0378-0782-93 D-0428-2019
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
Class II · Moderate risk

FEXOFENADINE HCl Tablet

Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD46257_13, EXP: 5/15/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-568-2014
Class II · Moderate risk

Fexofenadine HCL

Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: AD62992_8, EXP: 5/23/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-554-2014