Fexofenadine Hydrochloride Tablets recall
FDA recall D-0654-2026 · initiated Jun 1, 2026
SUN PHARMACEUTICAL INDUSTRIES INC recalled Fexofenadine Hydrochloride Tablets in Jun 2026 — an FDA Class III recall (D-0654-2026) because Failed Impurities/Degradation Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 9,048 bottles
Details
- 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
- Recalling company
- Sun Pharm Industries
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Jun 1, 2026
- FDA report date
- Jul 8, 2026
Frequently asked
- Was Fexofenadine Hydrochloride Tablets recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Fexofenadine Hydrochloride Tablets in Jun 2026 — an FDA Class III recall (D-0654-2026) because Failed Impurities/Degradation Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Fexofenadine Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0654-2026 was: Failed Impurities/Degradation Specifications
- Is a recalled Fexofenadine Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fexofenadine Hydrochloride Tablets are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0654-2026.