CLASS II Drug recall · Reported 22 Feb 2017 · FDA Enforcement Report

Lisinopril tablets, 5 mg recalled by Accord Healthcare

Accord Healthcare is recalling Lisinopril tablets, 5 mg, distributed nationwide in the US. The recall was initiated on 20 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # T04483, T04484, Exp 2/18; T06028, Exp 4/18; T08423, Exp 5/18
Quantity recalled12896 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0478-2017
FDA event ID
76105
Recalling firm
Accord Healthcare, Durham, NC
Classification
Class II
Status
Terminated
Recall initiated
20 Dec 2016
FDA classified
16 Feb 2017
Reported
22 Feb 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

20 Dec 2016Recall initiated by company
16 Feb 2017Classified by FDA+58 days
22 Feb 2017Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

U.S. Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # T04483, T04484, Exp 2/18; T06028, Exp 4/18; T08423, Exp 5/18

Where was it sold?

U.S. Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Accord Healthcare

All 106
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DrugCLASS IILevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide
DrugCLASS IILevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine SodiumAccord HealthcarePotency & AssayNationwide

Other Lisinopril recalls

All 38
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recalledLisinopril And HydrochlorothiazideLupin PharmaceuticalsPackaging DefectsNationwide
DrugCLASS IILisinopril Tablets, USP 10 mg recalled by Evaric PharmaceuticalsLisinoprilEvaric PharmaceuticalsForeign MaterialNationwide
DrugCLASS IILisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg recalledLisinopril And HydrochlorothiazideCardinal HealthcareManufacturing (CGMP) DeviationsNationwide
DrugCLASS IILisinopril Tablets USP, 10 mg recalled by Lupin PharmaceuticalsLisinoprilLupin PharmaceuticalsForeign MaterialNationwide
DrugCLASS IILisinopril Tablets USP, 10 mg recalled by Lupin PharmaceuticalsLisinoprilLupin PharmaceuticalsOtherNationwide