FDA recall D-0532-2025

Lupin Pharmaceuticals Inc. · Class II · drug

Product

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

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.

Distribution

Product was distributed nationwide within the United States.

Key facts

Status
Ongoing
Initiation date
2025-06-20
Report date
2025-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0532-2025