Sun Pharmaceutical Industries Inc is recalling 110,743 bottles of Tadalafil Tablets (tadalafil) sold under the Northstar Rx LLC label in 5 mg and 20 mg strengths. The recall was initiated because an incorrect grade of an inactive ingredient, Crospovidone, was used during manufacturing. No injuries or adverse events have been reported to date, but consumers should consult their healthcare provider if they have concerns about the medication's effectiveness or safety. The affected products were distributed nationwide to one distributor and were manufactured in both India and the United States.
The use of an incorrect grade of an inactive ingredient can lead to an incorrect product formulation, which may affect how the medication dissolves or is absorbed by the body. This could potentially impact the efficacy of the drug in treating conditions like erectile dysfunction or symptoms of an enlarged prostate.
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Manufactured for Northstar Rx LLC by Sun Pharmaceutical Industries Limited, India.
Manufactured for Northstar Rx LLC by Sun Pharmaceutical Industries Limited, India.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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
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