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.
What this means for you
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. The hazard is a theoretical risk of cross-contamination due to a manufacturing cleaning failure, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Methylprednisolone Tablets, USP, 4 mg, 100 tablets, Rx only. The affected product is manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and is identified by NDC 68382-916-01. The recall involves 34,521 100-count bottles 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 affected lots are M800144 and M800145 (Expiration: Feb-20), M808193 (Expiration: Jun-20), and M811096 (Expiration: Jul-20).
Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement. No specific instructions for immediate patient action beyond identifying the product are provided in the source text.
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 (8)
- Lots: M800144
- M800145
- EXP
- Feb-20
- M808193
- EXP Jun-20
- M811096
- EXPJul-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 Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above 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 →- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
- ModeratePrimidone tablets recalled over potential acemetacin cross-contamination at API manufacturer
FDA (Drugs) · 2026-06-17
- HighFly By Jing creamy sesame noodles may contain undeclared peanut
FDA (Food) · 2026-06-03
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets 50 mg Recalled for API Cross-Contamination
FDA (Drugs) · 2026-05-27