Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Lisinopril Tablets USP Recalled by Lupin Pharmaceuticals Inc. Due to CGMP Deviations: finished products manufactured using active pharmaceutical...

Date: April 6, 2016
Company: Lupin Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lupin Pharmaceuticals Inc. directly.

Affected Products

Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.

Quantity: 5,880 bottles

Why Was This Recalled?

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Where Was This Sold?

All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.

About Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report