Zydus Hydrocortisone Sodium Succinate Recall: FDA Class II Notice

Zydus Pharmaceuticals (USA) Inc. recalled Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial on October 1, 2026, because the product failed impurities and degradation specifications. The U.S. Food and Drug Administration (FDA) classified the action as Class II on October 13, 2026, and listed it in the agency’s enforcement report data on October 21, 2026. The recall covers 70,776 vials distributed nationwide within the United States and remains ongoing.

At a glance

• Recall number D-0039-2027 was assigned by the FDA to a voluntary, firm-initiated recall by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey.
• The reason recorded by the FDA is “Failed Impurities/Degradation Specifications.”
• The affected lots are LB00047A and LB00048A, both with an expiration date of 03/2028.
• The recalled product is Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, NDC 70710-1907-1, manufactured by Zydus Lifesciences Ltd., Vadodara, India.
• The FDA assigned the recall a Class II classification, which the agency’s enforcement data lists as “Ongoing.”

What the FDA recall record shows

The FDA enforcement report for recall number D-0039-2027 identifies the recalling firm as Zydus Pharmaceuticals (USA) Inc., at 73 Route 31 N, Pennington, NJ 08534-3601. The product description reads: Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.

The recall covers 70,776 vials. The distribution pattern recorded by the FDA is nationwide within the United States. The FDA lists the product’s routes of administration as intramuscular and intravenous, and the product type as a human prescription drug.

The FDA record states the reason for the recall as “Failed Impurities/Degradation Specifications.” The record does not describe which impurity or degradation product was out of specification, how far the affected lots deviated, or what testing produced the finding.

The FDA’s general drug recall page explains that a recall is a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk. In this matter the FDA’s enforcement data records the action as “Voluntary: Firm initiated,” with initial firm notification by letter.

What Class II means under FDA classification

The FDA enforcement data describes this recall as Class II. The FDA drug recall page supplied here explains the agency’s terminated-recall field, noting that a terminated recall is one where the FDA has determined all reasonable efforts have been made to remove or correct the product and proper disposition has been made according to the degree of hazard. That page does not spell out the definition of Class II, so this article does not restate a definition beyond the label itself.

Two points follow from the record. First, the recall is not shown as terminated. The FDA enforcement entry lists the status as “Ongoing.” Second, a classification is an FDA hazard assessment applied to a recall, not a finding that any particular person was harmed.

What is established vs. what is alleged

Established in the source record: the firm, the recall number, the product and NDC, the two lot numbers, the expiration date, the quantity of 70,776 vials, the nationwide distribution, the voluntary and firm-initiated character of the action, the notification by letter, the FDA classification date, the report date, and the stated reason.

Not established by these sources: that any patient was injured, that any lot reached a particular pharmacy or hospital, that a recall notice was sent to any specific customer, or that the FDA has taken any enforcement action beyond classifying the recall. The reason phrase “Failed Impurities/Degradation Specifications” is the firm’s and the agency’s stated basis for the recall, not an adjudicated finding about any individual dose.

No lawsuit, claim, or court proceeding concerning this recall appears in the supplied documents.

Where the claims stand procedurally

There is no federal consolidation of claims related to this recall in the supplied documents. No multidistrict litigation (MDL, a procedure that centralizes related federal lawsuits before one judge) is identified, and no docket number is provided. No bellwether trial (a test case selected from a group of similar lawsuits to gauge how others might resolve) is identified, and no trial date appears.

For context on how consolidated pharmaceutical matters are structured, the site’s page on sartan recalls and litigation and its page on the Zantac ranitidine litigation describe those separate matters and do not concern this product. A separate recall page covers American Health Packaging metoclopramide tablets.

The supplied documents include no court order or ruling, no regulatory enforcement action beyond the recall classification, no settlement, and no verdict connected to Hydrocortisone Sodium Succinate for Injection.

Key dates

• October 1, 2026: the recall initiation date recorded by the FDA.
• October 13, 2026: the FDA center classification date, when the recall was assigned Class II.
• October 21, 2026: the FDA report date for recall number D-0039-2027.
• March 2028: the expiration date recorded for lots LB00047A and LB00048A.

What this does not establish

The record does not say how many vials remain unaccounted for. It does not identify the testing method or the specification limit that was missed. It does not state whether any product was returned, destroyed, or relabeled. It does not say whether the FDA will reclassify the recall, terminate it, or take further action. It does not establish that any person received a vial from the affected lots, and it does not support a statement about the safety of any other lot of the same product.

Frequently asked questions

What did Zydus Pharmaceuticals (USA) Inc. recall in October 2026?

Zydus Pharmaceuticals (USA) Inc. recalled Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, NDC 70710-1907-1, under FDA recall number D-0039-2027. The FDA recorded the reason as “Failed Impurities/Degradation Specifications.” The action covered 70,776 vials and was initiated on October 1, 2026.

Which lots of the Zydus hydrocortisone sodium succinate recall are affected?

The FDA record lists lot LB00047A and lot LB00048A, both with an expiration date of 03/2028. The product is described as manufactured by Zydus Lifesciences Ltd., Vadodara, India, and distributed by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey. The distribution pattern recorded by the FDA is nationwide within the United States.

What does Class II mean for the Zydus hydrocortisone sodium succinate recall?

The FDA enforcement data assigns recall number D-0039-2027 a Class II classification, dated October 13, 2026. The classification is the FDA’s hazard assessment of the recall, and the entry lists the recall status as “Ongoing.” A classification is not a finding that any individual was harmed.

Is there litigation over the Zydus hydrocortisone sodium succinate recall?

No lawsuit or court proceeding concerning this recall appears in the supplied documents. No MDL number, docket number, trial date, or settlement is identified. The recall by Zydus Pharmaceuticals (USA) Inc. is recorded as a voluntary, firm-initiated action in the FDA enforcement data.

Sources

1. U.S. Food and Drug Administration (openFDA): “Drug Enforcement Report, Recall Number D-0039-2027” (link, accessed 2026-10-30)
2. U.S. Food and Drug Administration: “Drug Recalls” (link, accessed 2026-10-30)
3. U.S. Food and Drug Administration: “Drug Safety Communications” (link, accessed 2026-10-30)
4. U.S. Food and Drug Administration: “Drugs@FDA Data Files” (link, accessed 2026-10-30)
5. U.S. Food and Drug Administration: “What’s New: Drugs RSS Feed” (link, accessed 2026-10-30)
6. U.S. Food and Drug Administration: “Drug Safety and Availability” (link, accessed 2026-10-30)