West-Ward Columbus Inc recalls Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp.,
West-Ward recalls Ethacrynic Acid Tablets due to impurity and degradation issues. This prescription drug may have unsafe levels of impurities that could affect safety. Consumers should check their product details and contact the manufacturer for guidance.
Recall notice
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Contact the company & request your remedy
What happened, in plain English
West-Ward is recalling Ethacrynic Acid Tablets (25 mg, 100 tablets per bottle) because they failed impurity and degradation tests. This could pose a safety risk if the tablets contain unsafe levels of impurities or degradants. Read more at govinfonow.com/recall/37121-west-ward-ethacrynic-acid-tablets-recall-impurity-risk-in-drug.
Source Summary by GovInfoNow · govinfonow.com/recall/37121-west-ward-ethacrynic-acid-tablets-recall-impurity-risk-in-drug · Updated October 5, 2026 · FDA enforcement record: FDA #D-1282-2020
Cite this page
“West-Ward Ethacrynic Acid Tablets Recall: Impurity Risk in Drug Product.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37121-west-ward-ethacrynic-acid-tablets-recall-impurity-risk-in-drug. Based on FDA recall #D-1282-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1282-2020%22&limit=1).
Why it’s dangerous
The tablets failed impurity and degradation specifications, meaning they contain unsafe levels of impurities or degradants. This could potentially affect the drug's safety and effectiveness, though the exact risk to users is not clearly described in the recall.
Who’s affected
Prescription drug users who have the specific Ethacrynic Acid Tablets with NDC 0054-0415-25 and lot number AA4424A. Patients using this medication for conditions like edema may be at risk.
How to tell if you have this one
Check for the product name 'Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle' with NDC code 0054-0415-25 and lot number AA4424A. The product was distributed by West-Ward Pharmaceuticals Corp. in Eatontown, NJ.
- Brand
West-Ward- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 0054-0415-25 and lot number AA4424A on the product label.
Questions people ask
Is this product safe to use?
The recall states the tablets failed impurity and degradation tests, but the exact risk to users is not clearly described. Consult your healthcare provider for guidance.
How can I check if I have the recalled product?
Check the product label for NDC code 0054-0415-25 and lot number AA4424A. The product was distributed by West-Ward Pharmaceuticals Corp. in Eatontown, NJ.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact West-Ward Pharmaceuticals Corp. for further instructions.
Contact West-Ward
We’ve drafted a message you can send West-Ward to request your refund or repair — edit it as you like.
Subject: Recall D-1282-2020 — West-Ward West-Ward Hello, I own a West-Ward that is covered by recall D-1282-2020 from West-Ward. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1282-2020 (May 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1282-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.