Reported Jun 26, 2019 · Terminated

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC…

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only
  • Manufactured byCadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
Lot codes and dates
  • Lots
    • M713224
    • M713225
    • M713226
    • EXP Nov-19
    • M814746 EXP Sep-20
    • M816148 EXP Oct-20
    • M901600
    • M901601 EXP Feb-21
Amount recalled
40872 25-count bottles

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 16, 2021 · Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.