CLASS III Drug recall · Reported 27 May 2020 · FDA Enforcement Report
Ethacrynic Acid Tablets USP, 25 mg recalled by West-Ward Columbus
West-Ward Columbus is recalling Ethacrynic Acid Tablets USP, 25 mg per, distributed nationwide in the US. The recall was initiated on 13 May 2020 and the FDA has classified it as Class III.
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-1282-2020
- FDA event ID
- 85709
- Recalling firm
- West-Ward Columbus, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 May 2020
- FDA classified
- 29 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 May 2020 | Recall initiated by company | |
| 27 May 2020 | Published in enforcement report | +14 days |
| 29 May 2020 | Classified by FDA | +2 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 for impurity 6 and total degradants.
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
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Which lots are affected?
Lot #: AA4424A, Exp. 07/31/2020
Where was it sold?
Nationwide in the US
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Columbus
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets recalledMethadone Hydrochloride | West-Ward Columbus | Other | Nationwide |
| Drug | CLASS III | Methotrexate Tablets, USP, 2.5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS III | Leucovorin Calcium Tablets USP, 10 mg recalled by West-Ward ColumbusLeucovorin Calcium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS II | Doxycycline Hyclate Tablets USP, 100 mg recalled by West-Ward ColumbusDoxycycline Hyclate | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled | West-Ward Columbus | Potency & Assay | Nationwide |