LISINOPRIL AND HYDROCHLOROTHIAZIDE
Recalling Firm / Manufacturer: Lupin Pharmaceuticals Inc.
(Naples, FL, United States)
FDA Recall Number: D-0532-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Generic Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Active Substance(s)
Hydrochlorothiazide, Lisinopril
Administration Route
Oral
National Drug Code (NDC)
68180-518
Total Quantity Recalled
58,968 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
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.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
July 23, 2025
Firm Initiation Date
June 20, 2025
FDA Classification Date
Jul 17, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: QA01081, Exp. Date April 2027
Distribution Information
Geographic scope of affected shipments
Product was distributed nationwide within the United States.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0532-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508615UTCC