CLASS II Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report

Lisinopril Tablets, USP, 5 mg recalled by West-Ward Pharmaceutical

West-Ward Pharmaceutical is recalling Lisinopril Tablets, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 30 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 68679A, 68679C, Exp 01/15; 64456A, Exp 04/15; 68980A, Exp 05/15; 69234A, 69235A, Exp 07/15; 69607A, Exp 11/15; 69609C, 69835A, Exp 01/16; b) 64455B, Exp 08/13; 64456C, Exp 04/14; 64457A, Exp 10/14, 68679B, 68680A, Exp 01/15; 68980B, Exp 05/15; 69607B, 69608A, Exp 11/15; 69609B, Exp 01/16; c) 64455A, 64455C, 64455D, Exp 08/13; 64456B, Exp 04/14; 64457B, Exp 10/14; 68680B, Exp 01/15; 68980C, 68981A, Exp 05/15; 69608B, Exp 11/15; 69609A, Exp 01/16; 70169A, Exp 05/16

Quantity recalled51,704 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-853-2013
FDA event ID: 65807
Recalling firm: West-Ward Pharmaceutical, Eatontown, NJ
Classification: Class II
Status: Terminated
Recall initiated: 30 Jul 2013
FDA classified: 8 Aug 2013
Reported: 14 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

30 Jul 2013	Recall initiated by company
8 Aug 2013	Classified by FDA	+9 days
14 Aug 2013	Published 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 Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.

Where it was distributed

Nationwide

Questions about this recall

Is Lisinopril Tablets, USP, 5 mg recalled?

Yes. West-Ward Pharmaceutical recalled Lisinopril Tablets, USP, 5 mg on 30 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-853-2013.

Why was it recalled?

Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.

Which lots are affected?

Lot #: a) 68679A, 68679C, Exp 01/15; 64456A, Exp 04/15; 68980A, Exp 05/15; 69234A, 69235A, Exp 07/15; 69607A, Exp 11/15; 69609C, 69835A, Exp 01/16; b) 64455B, Exp 08/13; 64456C, Exp 04/14; 64457A, Exp 10/14, 68679B, 68680A, Exp 01/15; 68980B, Exp 05/15; 69607B, 69608A, Exp 11/15; 69609B, Exp 01/16; c) 64455A, 64455C, 64455D, Exp 08/13; 64456B, Exp 04/14; 64457B, Exp 10/14; 68680B, Exp 01/15; 68980C, 68981A, Exp 05/15; 69608B, Exp 11/15; 69609A, Exp 01/16; 70169A, Exp 05/16

Where was it sold?

Nationwide

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 21 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 West-Ward Pharmaceutical

All 30

Reported	Class	Recall	Company	Reason	Where
12 Oct 2016Drug	CLASS II	PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone	West-Ward Pharmaceutical	Other	Nationwide
24 Jun 2015Drug	CLASS III	Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) 05 mg/mL) recalledFentanyl Citrate	West-Ward Pharmaceutical	Potency & Assay	Nationwide
1 Apr 2015Drug	CLASS III	Fentanyl Citrate Inj., USP, CII, 250 mcg recalledFentanyl Citrate	West-Ward Pharmaceutical	Potency & Assay	Nationwide
5 Nov 2014Drug	CLASS II	Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled	West-Ward Pharmaceutical	Potency & Assay	GA
9 Jul 2014Drug	CLASS II	Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical	West-Ward Pharmaceutical	Potency & Assay	Nationwide

Other Lisinopril recalls

All 34

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025Drug	CLASS II	Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recalledLisinopril And Hydrochlorothiazide	Lupin Pharmaceuticals	Packaging Defects	Nationwide
27 Nov 2024Drug	CLASS II	Lisinopril Tablets, USP 10 mg recalled by Evaric PharmaceuticalsLisinopril	Evaric Pharmaceuticals	Foreign Material	Nationwide
3 Jan 2024Drug	CLASS II	Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg recalledLisinopril And Hydrochlorothiazide	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
21 Sep 2022Drug	CLASS II	Lisinopril Tablets USP, 10 mg recalled by Lupin PharmaceuticalsLisinopril	Lupin Pharmaceuticals	Foreign Material	Nationwide
5 Aug 2020Drug	CLASS II	Lisinopril Tablets USP, 10 mg recalled by Lupin PharmaceuticalsLisinopril	Lupin Pharmaceuticals	Other	Nationwide