Zydus Recalls Hydrocortisone Sodium Succinate Injection for Impurity Failures
Zydus Pharmaceuticals is recalling 70,776 vials of Hydrocortisone Sodium Succinate for Injection due to failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source identifies the hazard as failed impurities and degradation specifications in a Class II drug recall. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling 70,776 vials of Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial. The product is distributed nationwide within the United States. The recall is due to failed impurities and degradation specifications.
The affected product is identified by Lot numbers LB00047A and LB00048A, with an expiration date of 03/2028. The drug is a prescription-only medication manufactured by Zydus Lifesciences Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, NJ.
Healthcare providers and patients should discontinue use of the affected lots and contact their healthcare provider for further instructions. The FDA classifies this recall as Class II.
The recalled product
- Product
- HYDROCORTISONE SODIUM SUCCINATE (HYDROCORTISONE SODIUM SUCCINATE)
- Brand
- HYDROCORTISONE SODIUM SUCCINATE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Injection
- Hazard
- Affected units
- 70,776
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: LB00047A
- LB00048A
- Exp. Date 03/2028
Distribution
Distributed nationwide across the United States.
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