SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets
- Recalling company
- SUN PHARMACEUTICAL INDUSTRIES INC
- 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
- Reason
- Failed Impurities/Degradation Specifications
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jun 1, 2026
- Reported
- Jul 8, 2026
- Distribution
- U.S. Nationwide
- Status
- Ongoing
- Quantity
- 9,048 bottles
- Lot / codes
- Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
- Company location
- Princeton, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0654-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0654-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.