FDA Drugs recall ·
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg… recall
- Recall number
- D-0532-2025
- Date
- (initiated June 20, 2025)
- Company / brand
- Lupin Pharmaceuticals Inc.
5801 Pelican Bay Blvd, Naples, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 58,968 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: QA01081, Exp. Date April 2027
Distribution
Product was distributed nationwide within the United States.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0532-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.