Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
Zydus Pharmaceuticals is recalling Methylprednisolone tablets due to cross-contamination caused by cleaning failures. The affected lots are distributed nationwide.
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 is a reasonable probability of 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 known high-risk pathogen or structural defect.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Methylprednisolone Tablets, USP 4 mg, 21 Tablets dosepack, Rx Only. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving cross-contamination with other products resulting from a cleaning failure.
The affected product is distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the recall documentation, ranging from February 2020 to March 2021.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for a refund or replacement.
The recalled product
- Product
- METHYLPREDNISOLONE (METHYLPREDNISOLONE)
- Brand
- METHYLPREDNISOLONE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Drug
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 (20)
- Lots: M800150 Feb-20
- M803930
- M806006
- M806007
- M806008
- M806009
- M806010
- M806011
- EXP Mar-20
- M807299
- M807300
- M807301
- M807302
- M807303
- M807304
- M807305
- M807306
- M807307
- M807308
- EXP May-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
Same brand · METHYLPREDNISOLONE
- HighMethylprednisolone dose packs recalled over misoriented blister foil dosing information
FDA (Drugs) · 2026-02-04
- ModerateZydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
FDA (Drugs) · 2019-06-26
- HighZydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
FDA (Drugs) · 2019-06-26
- ModerateZydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
FDA (Drugs) · 2019-06-26
- ModerateZydus Recalls Methylprednisolone Tablets Due to Cross-Contamination
FDA (Drugs) · 2019-06-26
Same manufacturer · Zydus Pharmaceuticals USA Inc
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
Same hazard · cross contamination
See all →- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
Similar recalls
- LowAmerican Health Packaging Recalls Subpotent Methylprednisolone Tablets
FDA (Drugs) · 2014-10-29
- SevereZydus Recalls Promethazine Hydrochloride Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2014-05-28
- HighPrednisone Tablets Recalled for Contamination With Wrong-Strength Tablets
FDA (Drugs) · 2022-08-17
- ModerateMethylprednisolone Tablets Recalled for Potential Impurity Specification Failure
FDA (Drugs) · 2012-07-04
- SevereZydus Recalls Paroxetine Tablets Due to Presence of Risperidone
FDA (Drugs) · 2017-12-06
- LowJubilant Cadista Recalls Methylprednisolone Tablets for Stability Failure
FDA (Drugs) · 2018-09-26