Zydus Pharmaceuticals USA Inc recalls Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare
Zydus Pharmaceuticals recalls 50mg/vial Ethacrynate Sodium injections due to cGMP deviations. Affected lots manufactured in India, distributed in US. Consumers should contact for details.
Recall notice
cGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Zydus Pharmaceuticals is recalling Ethacrynate Sodium injections that were manufactured by Cadila Healthcare in India. The recall is due to cGMP deviations, which means the product may not meet quality standards. This affects patients who have been prescribed this medication. Read more at govinfonow.com/recall/37390-zydus-ethacrynate-sodium-injection-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37390-zydus-ethacrynate-sodium-injection-recall-cgmp-deviations-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0834-2020
Cite this page
“Zydus Ethacrynate Sodium Injection Recall: Cgmp Deviations Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37390-zydus-ethacrynate-sodium-injection-recall-cgmp-deviations-risk. Based on FDA recall #D-0834-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0834-2020%22&limit=1).
Why it’s dangerous
cGMP deviations refer to failures in the manufacturing process that could affect product quality. This means the medication might not be safe or effective for patients. However, the specific risks are not clearly described in the recall notice.
Who’s affected
Patients prescribed Ethacrynate Sodium injections for medical use are affected. Healthcare providers who dispensed these injections may also be impacted.
How to tell if you have this one
Check the product label for the lot numbers M804062 (expiring 01/2020) or M804063/M804064 (expiring 02/2020). The product is a 50mg/vial injection for prescription use only.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the lot numbers M804062 (expiring 01/2020) or M804063/M804064 (expiring 02/2020) on the vial.
Questions people ask
Why is this product being recalled?
The recall is due to cGMP deviations, which means the manufacturing process did not meet quality standards.
What should I do if I have this product?
The recall notice does not specify a remedy, so contact Zydus Pharmaceuticals for instructions.
Is this product safe to use?
The recall notice does not provide details on the specific risks, so it is unknown if the product is safe.
Contact Zydus Pharmaceuticals
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0834-2020 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0834-2020 from Zydus Pharmaceuticals. 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-0834-2020 (January 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0834-2020 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.