FDA recall, , Low risk
Sun Pharmaceutical Fexofenadine Hydrochloride Tablets
Fexofenadine Hydrochloride Tablets failed impurities and degradation specifications.
Summary by Recall Canary from the FDA notice
What happened
Sun Pharmaceutical Industries Inc., of Princeton, New Jersey, recalled Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, distributed by Ohm Laboratories, Inc., New Brunswick, NJ 08901, because the product failed impurities and degradation specifications. The company began the recall on June 1, 2026, and the FDA classified it on June 30, 2026.
The recall involved 9,048 bottles distributed nationwide in the U.S. and was added to the FDA's Enforcement Report on July 13, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine
- NDC
- 66336-561-30
- Lot code
- DNG0283A
- DNF0922A
- DNF0923B
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99110
- Recall number
- D-0654-2026
- Quantity recalled
- 9,048 bottles
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
Summary updated
