FDA Drugs recall ·
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine… recall
- Recall number
- D-0654-2026
- Date
- (initiated June 1, 2026)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 9,048 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
Distribution
U.S. Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0654-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.