Fexofenadine Hydrochloride Antihistamine Tablets Recalled for Microbial Contamination
Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Microbial contamination confirmed in manufacturing equipment of an oral pharmaceutical product represents a risk-of-harm scenario. Although no illnesses have been reported, the FDA's Class II classification and the inherent direct-exposure risk for a drug product with contaminated manufacturing process justify a High severity score.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to a manufacturing defect identified during a Good Manufacturing Practices (CGMP) inspection. The tablets are distributed nationwide by Ohm Laboratories Inc. and CVS Pharmacy under multiple NDC numbers.
The FDA classified this as a Class II recall after discovering microbial contamination in stagnant water within a duct of the manufacturing equipment. Approximately 54,504 bottles of affected product are involved. The recalled lot numbers include: DNE0792A, DNE1027A, DNE0793A, DNE0789A, DNE0790A, DNE0791A, and DNE1026A, with expiration dates in June and August 2025.
No illnesses or injuries have been reported to date. Consumers who have purchased Fexofenadine Hydrochloride 180mg tablets matching the recalled lot numbers should discontinue use and consult their pharmacist or healthcare provider for guidance on safe alternatives.
The recalled product
- Product
- FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
- Brand
- FEXOFENADINE HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- Affected units
- 54,504
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 #s: a) DNE0792A Exp. 06/31/2025
- DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A
- DNE0790A
- DNE0791A Exp. 06/2025
- DNE1026A Exp. 08/31/025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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