70,776 vials of injected hydrocortisone failed their impurity tests and are being recalled

Zydus Pharmaceuticals (USA) Inc. is recalling 70,776 vials of Hydrocortisone Sodium Succinate for Injection, USP, 100 mg per vial, because the product failed its impurity and degradation specifications. The recall covers two lots and went to wholesalers and customers across the United States. The U.S. Food and Drug Administration listed it in its enforcement report dated October 21, 2026.

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The company began the recall on October 1, 2026. FDA classified it as Class II on October 13, and the record still shows the recall as ongoing.

Recall D-0039-2027, two lots, 70,776 vials

The entry carries recall number D-0039-2027 and sits in the agency’s weekly drug enforcement report. The recalling firm is Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey, and the product is described as Hydrocortisone Sodium Succinate for Injection, USP, 100 mg per vial, one vial per package, prescription only, NDC 70710-1907-1. The label says it was manufactured by Zydus Lifesciences Ltd. in Vadodara, India. The affected lots are LB00047A and LB00048A, both with an expiration date of March 2028. The firm told its customers by letter, and the record classes the action as voluntary and firm-initiated.

FDA states the quantity as 70,776 vials, and the unit matters. A vial is one individual container of the powder that is mixed before injection, so the figure counts single units and not cartons, cases or bottles. The only reason the record gives is one line: failed impurities and degradation specifications. It does not name the impurity, report the measured values, say which test failed, or describe any patient complaint, and nothing in the record links the recall to an injury.

The dates show how the process unfolds. The firm’s own recall began on October 1, 2026, a Thursday. FDA’s classification, which assigns the Class II tier after reviewing the firm’s health-hazard reasoning, is stamped October 13, and the public listing carries a report date of October 21. The record is filed under event number 100017. Because the entry is marked ongoing, the firm is still working through its recall, and the agency has not yet recorded that every affected customer was reached or that the stock was retrieved.

Class II and what the tier means

FDA’s own recall definitions page sets out three tiers. The most serious covers products with a reasonable probability of causing serious harm or death. Class II applies where the probability of serious adverse health consequences is remote and any effects are temporary or medically reversible. The third tier covers products unlikely to cause adverse health consequences. A recall started on the company’s own initiative is the category commonly called voluntary, which is how the record labels the Zydus action. The agency’s classification date of October 13 came twelve days after the firm began pulling stock, and the public report followed eight days later.

Trade coverage of the entry, published by Medical Dialogues on October 23, repeats the same numbers and describes the Class II tier the same way. Neither that report nor the FDA record carries a statement from a named Zydus officer or an FDA official, so the enforcement entry itself is the whole public account of why the vials failed. The openFDA service that publishes these records carries its own caution that the data is unvalidated and should not be relied on for medical decisions, so the entry works as a public notice, and clinical questions about a specific lot belong with the manufacturer and a pharmacist.

Who depends on injectable hydrocortisone

Hydrocortisone is a corticosteroid that stands in for cortisol, the hormone the adrenal glands make. MedlinePlus, the National Library of Medicine’s drug-information service, describes the oral form as used to replace cortisol when the body does not make enough, and it warns that stopping the medicine suddenly can cause severe tiredness, weakness, dizziness and vomiting. That page covers tablets and liquids, not the injection. The Medical Dialogues report lists the injectable’s uses as acute adrenal insufficiency, severe allergic reactions, rheumatic disorders and other inflammatory conditions when oral treatment is not feasible. MedlinePlus has a patient page on hydrocortisone for the oral version.

Vials like these are stocked by hospitals, clinics and pharmacies and given by clinicians, so the practical check falls on whoever holds inventory: compare the lot number on the vial and carton with LB00047A and LB00048A and the March 2028 expiry. Stock from other lots or other manufacturers sits outside this recall. Hospital pharmacies and emergency departments that use the product often keep several suppliers on hand for this reason, since a single failed lot can otherwise leave a gap in supply for a drug used in time-sensitive situations such as adrenal insufficiency.

The record leaves three things open. It does not say how many of the 70,776 vials were still unused when the recall started, what impurity exceeded its limit, or whether replacement supply is on the way. The status field reads ongoing, and the number to watch is the date FDA eventually enters in the termination field.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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