SUN PHARMACEUTICAL INDUSTRIES INC has recalled 69,336 units of Loratadine-D Extended-Release Tablets and AllerClear D-24 hr (loratadine and pseudoephedrine sulfate). The recall was initiated because the products failed moisture limit testing during stability checks. While no injuries have been reported, consumers should contact their healthcare provider or pharmacist regarding the use of these allergy and congestion medications. These products were distributed nationwide in the United States in 10-count and 15-count blister packs.
The tablets failed to meet moisture level standards, which can affect the stability and effectiveness of the medication over time. This may result in the drug not performing as expected for treating allergy symptoms and nasal congestion.
Drug recall refund
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.