REGULATORY INTELLIGENCE·Recall
Lupin Pharmaceuticals Recalls Subpotent Rifampin Capsules Manufactured in India, Impacting US Supply Chains
Lupin Pharmaceuticals Inc. initiated a Class II recall for 15,576 bottles of Rifampin Capsules USP 150mg due to subpotency and failed impurity specifications. Manufactured by Lupin Limited in India, this impacts 32 US wholesalers and 156 distribution sites. The recall, D-0283-2024, was terminated on August 27, 2024, but highlights critical quality control vulnerabilities for procurement and regulatory teams.
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