Teva Pharmaceuticals USA recalls Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc.,
Teva Pharmaceuticals USA recalls Epoprostenol Sodium injection due to lack of sterility assurance. This sterile medication may contain harmful bacteria. Affected lots: 31326456B, exp. 02/28/2021.
Recall notice
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium injection vials because they may not be sterile. This could lead to infections if the medication is used. The recall affects specific lots with an expiration date of February 28, 2021. Read more at govinfonow.com/recall/36515-teva-epoprostenol-sodium-injection-recall-risk-of-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/36515-teva-epoprostenol-sodium-injection-recall-risk-of-contamination · Updated October 4, 2026 · FDA enforcement record: FDA #D-0280-2021
Cite this page
“Teva Epoprostenol Sodium Injection Recall: Risk of Contamination.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36515-teva-epoprostenol-sodium-injection-recall-risk-of-contamination. Based on FDA recall #D-0280-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0280-2021%22&limit=1).
Why it’s dangerous
The manufacturing process for these vials did not meet sterility standards, meaning they could contain harmful bacteria. If injected, this could cause serious infections or other health issues.
Who’s affected
Patients prescribed Epoprostenol Sodium injection by a doctor are affected. Those with the specific lot number 31326456B are at risk.
How to tell if you have this one
Check the product label for the lot number 31326456B and expiration date of February 28, 2021. The product is a 10 mL vial of Epoprostenol Sodium injection, 1.5 mg per vial, prescribed by a doctor.
- Brand
Teva Pharmaceuticals USA- Category
Drug
All 15 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
Product was distributed nationwide in the USA and Puerto Rico.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0271-2021 | Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.; Lot # 31326582B, exp. date 02/2022; Lot # 31326964B, exp. date 04/2022 | 50 vials | — |
| D-0272-2021 | Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.; Lot # 31326669B, exp. date 03/2021 | 2,577 vials | — |
| D-0273-2021 | Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.; Lot # 31326845B, exp. date 03/2021 Lot # 31327844B, exp. date 09/2021 | 26,373 vials | — |
| D-0274-2021 | Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01.; Lot # 31327537B, exp. date 09/2021 | 12,629 vials | — |
| D-0275-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.; Lot # 31327742B, exp. date 02/2021 Lot # 31328408B, exp. date 07/2021 | 5,086 vials | — |
| D-0276-2021 | Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.; Lot # 31326364B, exp. date 01/2022 31327120B, exp. date 05/2022 31327963B, exp. date 10/2022 | 248,565 vials | — |
| D-0277-2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.; Lot # 31325042B, exp. date 06/2021 31325336B, exp. date 07/2021 31326042B, exp. date 10/2021 31326137B, exp. date 11/2021 31326230B, exp. date 12/2021 31323816B, exp. date 02/2021 | 29,357 vials | 0703-4502-01, 0703-4502-04 |
| D-0278-2021 | Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01.; Lot # 31327600B, exp. date 08/2022 | 4,806 vials | — |
| D-0279-2021 | Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.; Lot # 31325712B, exp. date 12/2021 31326320B, exp. date 02/2022 31326457B, exp. date 02/2022 31327880B, exp. date 10/2022 | 33,6697 vials | — |
| D-0280-2021 | Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01.; Lot # 31326456B, exp. date 02/28/2021 | 12,609 vials | — |
| D-0281-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.; Lot # 31327909B, exp. date 04/2021 Lot # 31328352B, exp. date 07/2021 | 5,378 vials | — |
| D-0282-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0045-01.; Lot # 31327725B, exp. date 02/2021 Lot # 31327906B, exp. date 03/2021 | N/A | — |
| D-0283-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01.; Lot # 31328768B, exp. date 09/2021 | 6,710 vials | — |
| D-0284-2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01.; Lot # 31327738B, exp. date 03/2021 | 15,043 vials | — |
| D-0285-2021 | Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.; Lot # a) 31324653B, exp. date 03/2021; 31326066B, exp. date 11/2021; 31326428B, exp. date 02/2022; 31327949B, exp. date 10/2022; 31327995B, exp. date 10/2022; 31328031B, exp. date 11/2022; 31328217B, exp. date 12/2022; 31328325B, exp. date 12/2022; 31328425B, exp. date 07/2021; Lot # b) 31324480B, exp. date 02/2021; Lot # 31327396B, exp. date 08/2022 | 705,745 vials | — |
What to do — step by step
Check Product Label
Look for the lot number 31326456B and expiration date of February 28, 2021 on the vial.
Questions people ask
Is this product safe to use?
The recall indicates a risk of contamination, so it is not safe to use. The product may contain harmful bacteria.
What should I do if I have this product?
The official recall does not specify a remedy, so contact your doctor or Teva Pharmaceuticals USA for guidance.
How can I tell if I have the recalled product?
Check the vial label for lot number 31326456B and expiration date of February 28, 2021.
Contact Teva Pharmaceuticals USA
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0280-2021 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0280-2021 from Teva Pharmaceuticals USA. 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.
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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-0280-2021 (February 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0280-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.