CLASS II Drug recall · Reported 6 Mar 2013 · FDA Enforcement Report
Isoniazid Tablets recalled by West-ward Pharmaceutical
West-ward Pharmaceutical is recalling Isoniazid Tablets USP, distributed in Georgia. The recall was initiated on 4 Dec 2012 and the FDA has classified it as Class II.
Check your package
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-174-2013
- FDA event ID
- 64106
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2012
- FDA classified
- 27 Feb 2013
- Reported
- 6 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 4 Dec 2012 | Recall initiated by company | |
| 27 Feb 2013 | Classified by FDA | +85 days |
| 6 Mar 2013 | Published in enforcement report | +7 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; 36 month stability timepoint
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 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
Where it was distributed
GA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications; 36 month stability timepoint
Which lots are affected?
67079A; 67079B; 67079C
Where was it sold?
GA
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 |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) (0.05 mg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled | West-Ward Pharmaceutical | Potency & Assay | GA |
| Drug | CLASS II | Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
Other Isoniazid recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Isoniazid, Tablet, 300 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |