FDAClass IIJuly 19, 2023

Fexofenadine Hydrochloride Tablets recall: Impurity Out of Spec

Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.

Why was Fexofenadine Hydrochloride Tablets recalled?

Failed Impurities/Degradation Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: a) 2DV1869, 2EV1613, 2EV1614, Exp. date 12/23; 2EV1820, 2FV1943, Exp. date 01/24; 2GV1893, Exp. date 04/24. Lot #: b) 2CR0653, 2DR0466, Exp. date 12/23, 2ER2087, Exp. date 01/24

Product
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.
Recalling firm
L. Perrigo Company
Quantity
32,376 cartons
Distribution
Nationwide within the USA
Recall date
July 19, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls