MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lots: M800144, M800145, EXP, Feb-20; M808193, EXP Jun-20; M811096, EXPJul-20
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Zydus Pharmaceuticals USA Inc
Reason for Recall:
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

Product Codes/Lot Numbers:

Lots: M800144, M800145, EXP, Feb-20; M808193, EXP Jun-20; M811096, EXPJul-20

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1448-2019

Related Recalls

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Oct 22, 2025 Prescription Drugs Nationwide View Details →

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Oct 22, 2025 Prescription Drugs Nationwide View Details →