Use caution Drug recall · FDA · Published October 1, 2026

Zydus Recalls Hydrocortisone Sodium Succinate Injection Due to Impurities

Zydus recalls 70,776 vials of Hydrocortisone Sodium Succinate for injection due to failed impurity specifications. Check lot numbers LB00047A and LB00048A.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0039-2027Drug Zydus Pharmaceuticals ›

Use caution until it’s fixed

Failed Impurities/Degradation Specifications.

✎ GovInfoNow plain-language explainer

Zydus Pharmaceuticals has recalled Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial because the product failed impurity and degradation specifications. The recall affects 70,776 vials distributed nationwide in the United States. The record does not specify any injuries or health effects resulting from this defect. Read more at govinfonow.com/recall/1756677-zydus-pharmaceuticals-usa-inc-recalls-hydrocortisone-sodium-succinate-for-injection.

Source Summary by GovInfoNow · govinfonow.com/recall/1756677-zydus-pharmaceuticals-usa-inc-recalls-hydrocortisone-sodium-succinate-for-injection · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #D-0039-2027

Cite this page

“Zydus Recalls Hydrocortisone Sodium Succinate Injection Due to Impurities.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1756677-zydus-pharmaceuticals-usa-inc-recalls-hydrocortisone-sodium-succinate-for-injection. Based on FDA recall #D-0039-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0039-2027%22&limit=1).

The FDA announced on 2026-10-01 that Zydus Pharmaceuticals (USA) Inc is recalling Hydrocortisone Sodium Succinate for Injection due to failed impurity specifications. The voluntary Class II recall affects 70,776 vials distributed nationwide.

How to tell if you have it

Hydrocortisone Sodium Succinate Injection
100 mg/vial
NDC 70710-1907-1
Lot #: LB00047A, LB00048A
Exp. Date 03/2028

The hazard

The recall is due to failed impurities and degradation specifications for the drug product.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 54 other recalls on record since 2012-03-14. Recent brand recalls include a 2026-08-05 recall of Zydus Mirabegron 25mg Tablets for N-Nitroso impurity risk, a 2026-04-29 recall of Zydus Erythromycin Tablets for N-Nitroso-Desmethyl-Erythromycin risk, and a 2026-03-09 recall of Icosapent Ethyl Capsules due to defects. Other recent recalls of similar products include QuVa Pharma's 2026-06-24 Methohexital Sodium recall for impurity failures, Sagent's 2026-05-04 Busulfan Injection recall for failed impurities risk, and OneSource Specialty Pharma's 2026-06-07 Methohexital Sodium recall for impurities risk.

How to tell if you have this one

Check if you have Hydrocotisone Sodium Succinate for Injection, USP 100 mg/vial distributed by Zydus Pharmaceuticals (USA) Inc. Look for NDC 70710-1907-1 and Lot numbers LB00047A or LB00048A with an expiration date of 03/2028.

Brand
Zydus Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Inventory
Verify if your stock matches NDC 70710-1907-1 and lot numbers LB00047A or LB00048A.
Contact Your Supplier
Reach out to Zydus Pharmaceuticals or your distributor for further instructions on handling the recalled vials.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 20 days after the firm started it.

Oct 1, 2026Firm started the recall
Oct 13, 2026FDA classified it Class II
Oct 21, 2026Published in FDA’s Enforcement Report
Oct 27, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the NDC number for the recalled product?

The National Drug Code (NDC) is 70710-1907-1.

Similar recalls

Other Zydus Pharmaceuticals recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/1756677-zydus-pharmaceuticals-usa-inc-recalls-hydrocortisone-sodium-succinate-for-injection">Zydus Recalls Hydrocortisone Sodium Succinate Injection Due to Impurities (GovInfoNow)</a>

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-0039-2027 (October 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0039-2027 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 27, 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.