Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Ongoing
Report date
2025-07-23
Distribution
Product was distributed nationwide within the United States.
Firm state
FL
Product quantity
58,968 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Product description
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
Code / lot info
Lot #: QA01081, Exp. Date April 2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.