Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Dec 20, 2016 (10 years ago)

Lisinopril tablets

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

Why it was recalled

Failed tablet/capsule specification: missing break line on the 5mg tablet.

Cause type: Failed specification

A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.

What was recalled

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17

Affected NDC 16729-0376-17

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

Drug: Lisinopril Category: Blood Pressure Medication

Recalling firm
Accord Healthcare, Inc.
NDC code
16729-376-17
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0478-2017 · 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 Accord Healthcare, Inc.

All 2016 recalls