Sagent Pharmaceuticals Inc recalls methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent
Sagent Pharmaceuticals recalls 40mg methylprednisolone sodium succinate vials due to high impurity levels. Affected lots from India, expiring July 2018 and December 2018. Contact for return instructions.
Recall notice
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Contact the company & request your remedy
What happened, in plain English
Sagent Pharmaceuticals is recalling 40mg methylprednisolone sodium succinate injection vials because they contain high levels of an impurity that could be unsafe. This recall affects vials made in India with specific lot numbers and expiration dates. Patients using these vials should stop using them immediately and contact the manufacturer for instructions. Read more at govinfonow.com/recall/40792-sagent-methylprednisolone-sodium-succinate-40mg-vial-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40792-sagent-methylprednisolone-sodium-succinate-40mg-vial-recall-impurity-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0586-2018
Cite this page
“Sagent Methylprednisolone Sodium Succinate 40mg Vial Recall: Impurity Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40792-sagent-methylprednisolone-sodium-succinate-40mg-vial-recall-impurity-risk. Based on FDA recall #D-0586-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0586-2018%22&limit=1).
Why it’s dangerous
The vials contain high levels of an impurity that may not be safe for medical use. This impurity could potentially cause harm when the medication is administered, though the exact risk is not clearly described in the recall notice.
Who’s affected
Patients prescribed this medication by a healthcare provider. Those using the recalled vials with specific lot numbers and expiration dates are most at risk.
How to tell if you have this one
Check the vial label for the product name 'methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg per vial'. Look for lot numbers AJM601 (expiring July 2018) or AJM701, AJM702 (expiring December 2018).
- Brand
Sagent- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0586-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.; Lot #: AJM601, Exp. Jul-2018; AJM701, AJM702, Exp. Dec-2018 | 205,370 vials |
| D-0587-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.; Lot #: AJN601, Exp. Jun-2018; AJN701, AJN702, Exp. Dec-2018 | 176,410 vials |
| D-0588-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.; Lot #: AJP701, AJP702, Exp. Dec-2018; AJP601, Exp. Jul-2018; AJP703, Exp. Aug-2019 | 48,964 vials |
What to do — step by step
Stop Using Vial Now
Immediately stop using the recalled vial if you have it. Do not administer the medication.
Questions people ask
What is the specific impurity in the vial?
The recall record does not specify the exact impurity.
How can I check if my vial is affected?
Check the vial label for the product name and lot numbers AJM601 (expiring July 2018) or AJM701, AJM702 (expiring December 2018).
Do I need to return the vial?
The recall record does not state return instructions.
Contact Sagent
We’ve drafted a message you can send Sagent to request your refund or repair — edit it as you like.
Subject: Recall D-0586-2018 — Sagent Sagent Hello, I own a Sagent that is covered by recall D-0586-2018 from Sagent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0586-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0586-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.