Fexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Fexofenadine Hydrochloride Tablets, USP 180 mg distributed nationwide because the product failed impurities and degradation specifications. The recall affects approximately 9,048 bottles distributed across the United States.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for failed specifications without reported adverse health consequences. Class III recalls are by definition unlikely to cause adverse health consequences, placing this at the lowest severity tier.
Plain-English summary
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Fexofenadine Hydrochloride Tablets, USP 180 mg antihistamine medication. The product is supplied in bottles of 150 tablets and is distributed by Ohm Laboratories, Inc., of New Brunswick, NJ. The recall was initiated because the product failed impurities and degradation specifications.
The affected product has NDC 66336-561-30 and includes three specific lots: Lot DNG0283A (expiration 03/31/2027), Lot DNF0922A (expiration 10/31/2026), and Lot DNF0923B (expiration 10/31/2026). Approximately 9,048 bottles have been distributed nationwide.
Consumers who have purchased this product should contact their healthcare provider or pharmacist with questions about continued use. Customers who wish to return the product should contact the manufacturer or their dispensing pharmacy.
The recalled product
- 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
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Affected units
- 9,048
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot
- expiry: Lot DNG0283A
- exp 03/31/2027
- Lots DNF0922A and DNF0923B
- exp 10/31/2026
Distribution
Distributed nationwide across the United States.
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