June 2025 FDA Recall Lisinopril And Hydrochlorothiazide by Lupin Pharmaceuticals Inc.
D-0532-2025 - Product Mix Up
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on June 20, 2025 for the product Lisinopril And Hydrochlorothiazide. The FDA reported the reason for recall as product mix up. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0532-2025
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.
06-20-2025
07-23-2025
58,968 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide within the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : QA01081, Exp. Date April 2027
