Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories,
Summary
The FDA issued a Class III for Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per b by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0654-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
Product Description
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
Lot/Code Info: Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
Quantity Affected: 9,048 bottles
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-01
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 48 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 86 FDA actions in our database, including 85 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 86 FDA actions in our database, including 85 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0654-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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