D-0532-2025 Class II Ongoing

Recalled by Lupin Pharmaceuticals Inc. — Naples, FL

Recall Details

Product Type
Drugs
Report Date
July 23, 2025
Initiation Date
June 20, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58,968 bottles

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

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 Pattern

Product was distributed nationwide within the United States.

Code Information

Lot #: QA01081, Exp. Date April 2027