Zydus Pharmaceuticals MethylPREDNISolone Tablets Recall

Why it was recalled

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

Product description

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

Lot numbers, UPCs & expiration codes

Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1453-2019
Classification: Class II
Status: Terminated
Recall initiated: May 6, 2019
FDA report date: Jun 26, 2019
Quantity: 40872 25-count bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Zydus Pharmaceuticals USA Inc

Original FDA data

Every field from FDA enforcement report D-1453-2019, exactly as published.

Show all FDA fields

City: Pennington
State: NJ
Status: Terminated
Country: United States
Event ID: 82827
Address: 73 Route 31 N
Code information: Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21
Postal code: 08534-3601
Report date: Jun 26, 2019
Product type: Drugs
Recall number: D-1453-2019
Classification: Class II
Recalling firm: Zydus Pharmaceuticals USA Inc
Product quantity: 40872 25-count bottles
Termination date: Sep 16, 2021
Reason for recall: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Voluntary / mandated: Voluntary: Firm initiated
Product description: MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
Distribution pattern: Nationwide in the USA
Recall initiation date: May 6, 2019
Initial firm notification: Letter
Center classification date: Jul 1, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1453-2019, published Jun 26, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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