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
Reported: July 23, 2025 Initiated: June 20, 2025 #D-0532-2025
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
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 58,968 bottles
- Distribution
- Product was distributed nationwide within the United States.
- Location
- Naples, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 58,968 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2025. Severity: Moderate. Recall number: D-0532-2025.
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