FDAClass III · Drug · Recalled July 8, 2026

Fexofenadine Hydrochloride Tablets recall — SUN PHARMACEUTICAL INDUSTRIES INC

Hazard: Failed Impurities/Degradation Specifications

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0654-2026
Brand: SUN PHARMACEUTICAL INDUSTRIES
Classification: Class III
Units affected: 9,048 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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

Affected products

Fexofenadine Hydrochloride Tablets

Companies & origin

Recalling firm location: Princeton, NJ, United States
Firm address: 2 Independence Way, N/A, 08540-6620

Identifying details (verbatim from the notice)

Product codes / lots: Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
Distribution: U.S. Nationwide
Firm notified the public via: Letter
FDA event ID: 99110
Recall initiated: June 1, 2026
FDA classified: June 30, 2026
FDA report date: July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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