Sagent Recalls Atracurium Besylate Injection Due to Sterility Risks
Sagent Pharmaceuticals recalls specific lots of Atracurium Besylate Injection due to potential lack of sterility. Check lot numbers and expiration dates.
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Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
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What happened, in plain English
Sagent Pharmaceuticals is recalling Atracurium Besylate Injection, USP because there is a lack of assurance that the product remains sterile. This issue stems from FDA observations regarding aseptic and Good Manufacturing Practices at the manufacturing site. The recall affects 140,850 vials distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/44921-sagent-pharmaceuticals-inc-recalls-atracurium-besylate-injection-usp-100-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/44921-sagent-pharmaceuticals-inc-recalls-atracurium-besylate-injection-usp-100-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-0399-2015
Cite this page
“Sagent Recalls Atracurium Besylate Injection Due to Sterility Risks.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44921-sagent-pharmaceuticals-inc-recalls-atracurium-besylate-injection-usp-100-mg. Based on FDA recall #D-0399-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0399-2015%22&limit=1).
Why it’s dangerous
The primary hazard is a potential lack of sterility in the multi-dose vials. If the manufacturing process did not maintain proper aseptic conditions, the injection could be contaminated with microorganisms. Administering non-sterile intravenous medication can lead to serious infections or other complications for the patient.
Who’s affected
Healthcare providers and patients who have received or are using Atracurium Besylate Injection from the specific lots listed in the record. Patients relying on this intravenous medication are at risk if the product is not sterile.
How to tell if you have this one
Look for Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, in a 10 mL Multi-Dose Vial. Check the NDC number 25021-672-10 and verify if the lot number is VATB012, VATB013, VATB014 (Expiration 11/15) or VATB017 (Expiration 08/16).
- Brand
Sagent Pharmaceuticals- Category
Drug
All 2 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 and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0398-2015 | Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05; Lot Numbers: VATA012, Exp 11/15; VATA015, Exp 08/16 | 140,720 vials |
| D-0399-2015 | Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10; Lot Numbers: VATB012, VATB013, VATB014, Exp 11/15; VATB017, Exp 08/16 | 140,850 vials |
What to do — step by step
Check Lot Numbers
Verify if your vials match the recalled lot numbers: VATB012, VATB013, VATB014, or VATB017.
Stop Using Recalled Vials
Do not use any vials that match the recalled lot numbers due to sterility concerns.
Contact Manufacturer or Provider
Reach out to Sagent Pharmaceuticals or your healthcare provider for further instructions on disposal or replacement, as no specific remedy details are provided in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0399-2015 (February 23, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0399-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.