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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a manufacturing deviation (cross-contamination) rather than a high-risk pathogen or structural defect.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling specific lots of Methylprednisolone Tablets, USP 16 mg. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically cross-contamination with other products resulting from a cleaning failure.
The affected product is a prescription-only medication manufactured by Cadila Healthcare Ltd. in Ahmedabad, India. The recall covers lots M713034, M713035, and M713036 with an expiration date of November 2019; lot M814747 with an expiration date of September 2020; and lot M819266 with an expiration date of December 2020. The product was distributed nationwide in the USA.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- METHYLPREDNISOLONE (METHYLPREDNISOLONE)
- Brand
- METHYLPREDNISOLONE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
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 (7)
- lots: M713034
- M713035
- M713036
- EXP Nov-19
- M814747 Sep-20
- M819266
- EXP Dec-20
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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