CLASS II Drug recall · Reported 9 Jul 2014 · FDA Enforcement Report

Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical

West-Ward Pharmaceutical is recalling Isoniazid Tablets, USP, 300 mg, distributed nationwide in the US. The recall was initiated on 20 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14

Quantity recalleda) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 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-1414-2014
FDA event ID: 68502
Recalling firm: West-Ward Pharmaceutical, Eatontown, NJ
Classification: Class II
Status: Terminated
Recall initiated: 20 May 2014
FDA classified: 1 Jul 2014
Reported: 9 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

20 May 2014	Recall initiated by company
1 Jul 2014	Classified by FDA	+42 days
9 Jul 2014	Published in enforcement report	+8 days

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

Reason for recall

Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 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

Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.

Which lots are affected?

Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14

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 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 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) (0.05 mg/mL) recalledFentanyl Citrate	West-Ward Pharmaceutical	Potency & Assay	Nationwide
1 Apr 2015Drug	CLASS III	Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) 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
25 Dec 2013Drug	CLASS II	Carisoprodol Tablets, USP 350 mg recalled by West-Ward Pharmaceutical	West-Ward Pharmaceutical	Lead & Heavy Metals	Nationwide

Other Isoniazid recalls

All 3

Reported	Class	Recall	Company	Reason	Where
29 Jan 2014Drug	CLASS II	Isoniazid, Tablet, 300 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
6 Mar 2013Drug	CLASS II	Isoniazid Tablets recalled by West-ward Pharmaceutical	West-ward Pharmaceutical	Potency & Assay	GA