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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sagent Pharmaceuticals Inc: Methylprednisolone Sodium Succinate Recalled for High Impurity Levels

Agency Publication Date: March 12, 2018
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Summary

Sagent Pharmaceuticals is recalling 430,744 vials of methylPREDNISolone Sodium Succinate for Injection, USP, in 40 mg, 125 mg, and 1 gram doses. The recall was initiated because testing showed high levels of an impurity, meaning the drug failed to meet quality and degradation specifications. This medication is a generic steroid used to treat various conditions, and the presence of excessive impurities can affect the safety and effectiveness of the treatment. Consumers who have these vials should contact their healthcare provider or pharmacist, as these products were distributed nationwide.

Risk

The product contains levels of an impurity or degradation product that exceed safety specifications. Using a medication with higher-than-allowed impurities can lead to unpredictable side effects or reduced effectiveness of the steroid treatment.

What You Should Do

  1. Check your medication vials for the following NDC numbers: 25021-807-05 (40 mg), 25021-808-10 (125 mg), or 25021-810-30 (1 gram).
  2. Verify the lot numbers and expiration dates on the packaging: For 40 mg vials, look for AJM601 (Exp. Jul-2018), AJM701 (Exp. Dec-2018), or AJM702 (Exp. Dec-2018).
  3. For 125 mg vials, look for AJN601 (Exp. Jun-2018), AJN701 (Exp. Dec-2018), or AJN702 (Exp. Dec-2018).
  4. For 1 gram vials, look for AJP701 (Exp. Dec-2018), AJP702 (Exp. Dec-2018), AJP601 (Exp. Jul-2018), or AJP703 (Exp. Aug-2019).
  5. Contact your healthcare provider or pharmacist immediately for guidance if you have an affected vial. Do not use the medication if it matches the recalled lots.
  6. Return any unused product to the place of purchase for a refund and contact Sagent Pharmaceuticals at their Schaumburg, Illinois office for further instructions.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: methylPREDNISolone Sodium Succinate for Injection, USP (40 mg per vial)
Model:
NDC 25021-807-05
Recall #: D-0586-2018
Lot Numbers:
AJM601 (Exp. Jul-2018)
AJM701 (Exp. Dec-2018)
AJM702 (Exp. Dec-2018)
Date Ranges: Jul-2018, Dec-2018
Product: methylPREDNISolone Sodium Succinate for Injection, USP (125 mg per vial)
Model:
NDC 25021-808-10
Recall #: D-0587-2018
Lot Numbers:
AJN601 (Exp. Jun-2018)
AJN701 (Exp. Dec-2018)
AJN702 (Exp. Dec-2018)
Date Ranges: Jun-2018, Dec-2018
Product: methylPREDNISolone Sodium Succinate for Injection, USP (1 gram per vial)
Model:
NDC 25021-810-30
Recall #: D-0588-2018
Lot Numbers:
AJP701 (Exp. Dec-2018)
AJP702 (Exp. Dec-2018)
AJP601 (Exp. Jul-2018)
AJP703 (Exp. Aug-2019)
Date Ranges: Jul-2018, Dec-2018, Aug-2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79419
Status: Resolved
Manufacturer: Sagent Pharmaceuticals Inc
Manufactured In: India, United States
Units Affected: 3 products (205,370 vials; 176,410 vials; 48,964 vials)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.