CLASS II ONGOING Drug recall · Reported 21 Oct 2026 · FDA Enforcement Report
Hydrocortisone Sodium Succinate for Injection recalled
Zydus Pharmaceuticals is recalling Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, distributed nationwide in the US. The recall was initiated on 1 Oct 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0039-2027
- FDA event ID
- 100017
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Oct 2026
- FDA classified
- 13 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Oct 2026 | Recall initiated by company | |
| 13 Oct 2026 | Classified by FDA | +12 days |
| 21 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications.
Which lots are affected?
Lot #: LB00047A, LB00048A, Exp. Date 03/2028
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Hydrocortisone recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream recalledRapidol | Kenil Healthcare Private | Manufacturing (CGMP) Deviations | DE, NC |
| Drug | CLASS III | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalledHydrocortisone And Acetic Acid | Taro Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone and Acetic Acid Otic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone Ointment recalled by Mckesson Medical-SurgicalHydrocortisone | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrocortisone Acet 30mg recalled by Cardinal HealthHydrocortisone Acetate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |