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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
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 23, 2026 at 11:04 PM UTC.
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