Methylprednisolone recalls: 8 FDA reports
Recalls involving Methylprednisolone. What was wrong with each batch, and how the FDA graded the risk.
8Reports
0Class I
1Ongoing
2026-02-04Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distr
D-0299-2026 · Class II · reported 2026-02-04 · Ongoing
- Why it was recalled
- Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
- Product
- methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2
- Where it went
- Nationwide within the United States
- How much
- 3456 cartons
MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad,
D-1448-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Product
- MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01
- Where it went
- Nationwide in the USA
- How much
- 34521 100-count bottles
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad,
D-1453-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Product
- MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
- Where it went
- Nationwide in the USA
- How much
- 40872 25-count bottles
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad,
D-1450-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Product
- MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18
- Where it went
- Nationwide in the USA
- How much
- N/A
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by:
D-1449-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Product
- MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34
- Where it went
- Nationwide in the USA
- How much
- N/A
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad,
D-1451-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Product
- MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11
- Where it went
- Nationwide in the USA
- How much
- 13,564 25-count bottles
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Pa
D-0043-2015 · Class III · reported 2014-10-29 · Terminated
- Why it was recalled
- Subpotent; 6 month stability time point
- Product
- MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11
- Where it went
- Nationwide
- How much
- 2,005 cartons
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (N
D-1605-2014 · Class III · reported 2014-10-01 · Terminated
- Why it was recalled
- Subpotent; 6 month stability time point
- Product
- MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- Where it went
- Nationwide
- How much
- 159,913 tablets
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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