Fexofenadine Hydrochloride Tablets recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIIOngoing
Summary: SUN PHARMACEUTICAL INDUSTRIES INC is recalling 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.
What is being recalled
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
Why
Failed Impurities/Degradation Specifications
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
U.S. Nationwide
How to tell if yours is affected
Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0654-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | June 1, 2026 |
| Reported | July 8, 2026 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 9,048 bottles |
More recalls from SUN PHARMACEUTICAL INDUSTRIES INC · all drug recalls · recalls from June 2026