D-0654-2026 Class III Ongoing
FDA drug recall D-0654-2026 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on June 1, 2026 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is ongoing. Affected quantity: 9,048 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- June 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,048 bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
U.S. Nationwide
Code Information
Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026