FDA-Drug2025-07-23Class II

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

Lupin Pharmaceuticals Inc.
Hazard

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.

Sold states
Product was distributed nationwide within the United States.
Affected count
58,968 bottles
Manufactured in
5801 Pelican Bay Blvd, Suite 500, Naples, FL, United States
Products
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

Official notice

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

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