Jubilant Cadista Pharmaceuticals is recalling 744 bottles of Meclizine hydrochloride (12.5 mg), a medication used for motion sickness and vertigo. These specific 100-count bottles were released to the nationwide market before receiving final FDA approval of their marketing application. While no incidents or injuries have been reported, consumers should contact their doctor or pharmacist for advice regarding any tablets they may still possess from this specific batch. These Rx-only tablets were manufactured in Salisbury, Maryland, and distributed across the United States.
The drug was released prior to final regulatory approval, meaning it was marketed without the FDA's complete verification of its safety, effectiveness, and manufacturing standards. Products sold without an approved application have not undergone the full rigorous review required to ensure they are safe for public use.
Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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
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