Recalls / Class II
Class IID-0532-2025
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
- Brand name
- Lisinopril And Hydrochlorothiazide
- Generic name
- Lisinopril And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Lisinopril
- Route
- Oral
- NDCs
- 68180-518, 68180-519, 68180-520
- FDA application
- ANDA077912
- Affected lot / code info
- Lot #: QA01081, Exp. Date April 2027
Why it was 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.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 5801 Pelican Bay Blvd, Suite 500, Naples, Florida 34108-2755
Distribution
- Quantity
- 58,968 bottles
- Distribution pattern
- Product was distributed nationwide within the United States.
Timeline
- Recall initiated
- 2025-06-20
- FDA classified
- 2025-07-17
- Posted by FDA
- 2025-07-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0532-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.