Novel Laboratories, Inc. is voluntarily recalling 134,364 bottles (approximately 4 million tablets) of Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg. This prescription cough suppressant is being recalled because testing revealed the product failed to meet specifications for impurities and degradation. Consumers should check their medicine cabinets for the affected 30-count bottles distributed nationwide.
The presence of impurities or degradation products beyond specified limits means the medication may not meet safety and quality standards over time, though the risk level is currently classified as low.
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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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