FDAClass IIIJuly 8, 2026

Fexofenadine Hydrochloride Tablets recall: Impurity Out of Spec

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30

Why was Fexofenadine Hydrochloride Tablets recalled?

Failed Impurities/Degradation Specifications

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026

Product
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
9,048 bottles
Distribution
U.S. Nationwide
Recall date
July 8, 2026
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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