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.
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
Lot numbers, UPCs & expiration codes
Lot #: QA01081, Exp. Date April 2027
Where it was sold
Product was distributed nationwide within the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0532-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 20, 2025
- FDA report date
- Jul 23, 2025
- Quantity
- 58,968 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0532-2025, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 97118
- Address
- 5801 Pelican Bay Blvd
- Address (line 2)
- Suite 500
- Code information
- Lot #: QA01081, Exp. Date April 2027
- Postal code
- 34108-2755
- Report date
- Jul 23, 2025
- Product type
- Drugs
- Recall number
- D-0532-2025
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 58,968 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed nationwide within the United States.
- Recall initiation date
- Jun 20, 2025
- Center classification date
- Jul 17, 2025