Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Aug 13, 2018 (8 years ago)

Lisinopril Tablets USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03

Affected NDC 68180-0980-03

Compare with the code on your package — it is the most precise check available.

Drug: Lisinopril Category: Blood Pressure Medication

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Lisinopril
NDC 68180-0980
10 mg/1 Tablet
Oral
Lupin Pharmaceuticals, Inc. Rx
Recalling firm
Lupin Pharmaceuticals Inc.
NDC code
68180-980-03
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1077-2018 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Lisinopril recalls

See all
Class II · Moderate risk

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg

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.

Ongoing Labeling / mix-up Lupin Pharmaceuticals Inc. NDC 68180-519-01 D-0532-2025
Class II · Moderate risk

Lisinopril Tablets

Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.

Terminated Particulate / foreign matter Evaric Pharmaceuticals Inc. NDC 68645-610-90 D-0061-2025
Class III · Low risk

Lisinopril Tablets USP 20 mg

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

Terminated Particulate / foreign matter NCS Healthcare of Kentucky Inc NDC 0615-7718-05 D-0114-2024

Other recalls by Lupin Pharmaceuticals Inc.

All 2018 recalls