Class IIIOngoing
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets
Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)
Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.
- Company
- SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurities/Degradation Specifications
- Hazard
- FDA Class III: not likely to cause adverse health consequences (FDA definition).
- Who’s affected
- U.S. Nationwide
- Where
- Nationwide
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99110…
Products
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
Codes/lots: Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026Quantity: 9,048 bottlesRecall no. D-0654-2026Class III
Update history
- First listed on OVERLOOKED from the official record.
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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