RecallReported October 21, 2026

Class II recall by Zydus Pharmaceuticals (USA) Inc

Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510…

FDA's record ↗

FDA's enforcement report of October 21, 2026 lists a Class II recall by Zydus Pharmaceuticals (USA) Inc of Pennington, NJ. Product: Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510…. Status: Ongoing.

On the record

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Location
Pennington, NJ
Classification
Class II
Status
Ongoing
Recall number
D-0039-2027
Product type
Drugs
Brand names
HYDROCORTISONE SODIUM SUCCINATE
Generic names
HYDROCORTISONE SODIUM SUCCINATE
Recall initiated
2026-10-01
Reported by FDA
2026-10-21
Source
FDA enforcement reports ↗

The full record

An account shows the reason for the recall, where the product was distributed and the lots.

What a recall is

FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.

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From FDA enforcement reports. The record may have changed since it was read.

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