Sun Pharmaceutical Recalls Fexofenadine 180 mg Tablets Over Impurity Issue

Sun Pharmaceutical Industries Inc, through its subsidiary Ohm Laboratories Inc, has voluntarily recalled 9,048 bottles of Fexofenadine Hydrochloride Tablets, USP 180 mg, an over-the-counter antihistamine, after the product failed impurities and degradation specifications. The recall has been classified as Class III by the U.S. Food and Drug Administration, meaning the product is unlikely to cause adverse health consequences.

What Products Are Being Recalled?

The recalled product is Fexofenadine Hydrochloride Tablets, USP 180 mg, sold in bottles of 150 tablets under NDC 66336-561-30. The tablets are distributed by Ohm Laboratories Inc, based in New Brunswick, New Jersey. The affected lots include Lot DNG0283A, with an expiration date of 03/31/2027, and Lots DNF0922A and DNF0923B, both expiring 10/31/2026. In total, 9,048 bottles are covered under the recall.

Why Was This Recall Issued?

According to the FDA enforcement report, the recall was initiated because the affected lots failed impurities and degradation specifications. This means testing found that the tablets did not meet the required purity standards, which can occur when a drug product breaks down or degrades over time or during storage. The recall was voluntarily initiated by the firm and is classified as Class III, the FDA category reserved for situations where use of the product is not likely to cause adverse health consequences.

Who Is Affected?

The product was distributed nationwide across the United States. Consumers who purchased Fexofenadine Hydrochloride Tablets, USP 180 mg, particularly those who use it as an over-the-counter allergy medication, may be affected if their bottle matches one of the recalled lot numbers. Pharmacies, retailers, and distributors who received shipments of the affected lots are also impacted and should check their inventory against the recall notice.

What Should You Do?

Consumers and retailers who have bottles of Fexofenadine Hydrochloride Tablets, USP 180 mg, matching Lot DNG0283A, DNF0922A, or DNF0923B should check the lot number and expiration date printed on the bottle label. Since this is a Class III recall, immediate health risk is not expected, but consumers are advised to stop using the affected lots and consult their pharmacist or physician if they have concerns about the impurity issue. Anyone with questions about the recall should contact Sun Pharmaceutical Industries Inc or Ohm Laboratories Inc directly, or reach out to the pharmacy or retailer where the product was purchased for guidance on returns or replacement.

Official Statement

No press release has been issued for this recall. The recall was initiated by the firm on 6/1/2026 and was given a Center Classification Date of 6/30/2026 by the FDA. As of the latest update, the recall status remains ongoing, with no termination date reported.