Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, a Class II recall without reported adverse events or high-risk pathogens is typically scored as Moderate.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 40,872 bottles of MethylPREDNISolone Tablets, USP 8 mg. The affected product is distributed nationwide in the USA. The recall involves specific lots with expiration dates ranging from November 2019 to February 2021.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically cross-contamination with other products resulting from a cleaning failure. This contamination risk affects the safety and purity of the medication.
Consumers and healthcare providers should check their inventory for the affected lot numbers and expiration dates. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or supplier for disposal or credit.
The recalled product
- Product
- METHYLPREDNISOLONE (METHYLPREDNISOLONE)
- Brand
- METHYLPREDNISOLONE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Hazard
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 (8)
- Lots: M713224
- M713225
- M713226
- EXP Nov-19
- M814746 EXP Sep-20
- M816148 EXP Oct-20
- M901600
- M901601 EXP Feb-21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Zydus Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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