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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves cross-contamination of a prescription drug, which poses a risk of harm even without reported illnesses.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 13,564 bottles of MethylPREDNISolone Tablets, USP 32 mg (25-count). The affected lots are M713043, M713047 (EXP Dec-19), M713045 (EXP Nov-19), and M816143 (EXP Oct-20). These products were distributed nationwide in the USA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically cross-contamination with other products resulting from a cleaning failure. The agency has classified this recall as Class II.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. 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 Drug
- 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 (7)
- Lots: M713043
- M713047
- EXP Dec-19
- M713045
- EXP Nov- 19
- M816143
- EXP Oct-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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