CLASS II Drug recall · Reported 10 Apr 2013 · FDA Enforcement Report
Ethambutol Hydrochloride Tablets recalled by West-ward Pharmaceutical
West-ward Pharmaceutical is recalling Ethambutol Hydrochloride Tablets, USP per, distributed nationwide in the US. The recall was initiated on 18 Mar 2013 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-242-2013
- FDA event ID
- 64821
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2013
- FDA classified
- 3 Apr 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Mar 2013 | Recall initiated by company | |
| 3 Apr 2013 | Classified by FDA | +16 days |
| 10 Apr 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
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
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
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Which lots are affected?
Lot #: 68028A, Exp 07/14
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
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|---|---|---|---|---|---|
| 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 Ethambutol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ethambutol Hydrochloride Tablets USP, 400 mg recalledEthambutol Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |