Teva Epoprostenol Sodium Injection Recall: Lack of Sterility Risk
Teva Pharmaceuticals recalls Epoprostenol Sodium injection vials due to lack of sterility assurance. This drug, used for severe heart conditions, may cause infections if not properly sterile.
Lower-risk recall
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Teva Pharmaceuticals is recalling Epop: 1.5 mg/vial, 10 mL injection vials for potential lack of sterility. This could lead to infections if the medication is not sterile, which is critical for patients with heart conditions. Read more at govinfonow.com/recall/36000-teva-epoprostenol-sodium-injection-recall-lack-of-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36000-teva-epoprostenol-sodium-injection-recall-lack-of-sterility-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0738-2021
Cite this page
“Teva Epoprostenol Sodium Injection Recall: Lack of Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36000-teva-epoprostenol-sodium-injection-recall-lack-of-sterility-risk. Based on FDA recall #D-0738-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0738-2021%22&limit=1).
Why it’s dangerous
The medication may not be sterile, which can cause infections in patients who require precise medical treatments. This is especially concerning for individuals with heart conditions who rely on the drug.
Who’s affected
Patients prescribed this medication for heart conditions are affected. Those using the product without proper sterility checks are at higher risk.
How to tell if you have this one
Check for vials labeled 'Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL' with NDC 0703-1995-01 and lot number 31329113B, expiring May 2022.
- Brand
Teva Pharmaceuticals- Category
Drug
All 19 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, including Puerto Rico.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0730-2021 | DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13; Lot #: 31329250B, exp. date 08/2022 | 1,351 vials | — |
| D-0731-2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.; Lot #: a) 31328455B, exp. date 09/2021; 31329340B, exp. date 12/2021; 31329439B, exp. date 01/2022; 31328347B, exp. date 07/2021 b) 31328321B, exp. date 07/2021; c) 31328368B, 31328394B, exp. date 07/2021; 31328699B, exp. date 09/2021; 31328834B, exp. date 10/2021; 31329286B, exp. date 12/2021 | 193,845 vials | — |
| D-0732-2021 | Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.; Lot #: a) 31327056B, exp. date 03/2022; 31328547B, exp. date 01/2023; b) 31327066B, exp. date 03/2022 | 16,226 vials | — |
| D-0733-2021 | Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01; Lot #: 31329243B, exp. date 05/2022 | 4,712 vials | — |
| D-0734-2021 | Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11; Lot #: 31328668B, exp. date 04/2023 | 2,091 vials | — |
| D-0735-2021 | Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01; Lot #: 31325960B, exp. date12/2021; 31326111B, exp. date 01/2022; 31326875B, exp. date 03/2022; 31326915B, exp. date 03/2022; 31326916B, 31326917B, exp. date 04/2022; 31329079B, exp. date 04/2023; 31329085B, exp. date 05/2023 | 62,358 vials | — |
| D-0736-2021 | Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01; Lot #: 31329150B, exp. date 06/2022 | 16,644 vials | — |
| D-0737-2021 | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01; Lot #: 31325852B, 31325985B, exp. date 10/2021; 31326349B, exp. date 01/2022; 31326873B, exp. date 03/2022; 31326995B, exp. date 05/2022 31327158B, exp. date 06/2022; 31328946B, 31329180B, exp. date 05/2023. | 434,229 vials | — |
| D-0738-2021 | Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01; Lot #: 31329113B, exp. date 05/2022 | 12,698 vials | — |
| D-0739-2021 | Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01; Lot #: 31329045B, exp. date 07/2021; 31329077B, exp. date 08/2021; 31329312B, exp. date 09/2021 | 34,100 vials | — |
| D-0740-2021 | Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01; Lot #: 100022400, exp. date 04/2023 | 4,249 vials | — |
| D-0741-2021 | Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01; Lot #: 31326043B, exp. date 10/2021; 31326138B, exp. date 11/2021 31329399B, 31329539B, exp. date 08/2023; 31329599B, exp. date 09/2023 | 25,653 vials | 0703-4502-01, 0703-4502-04 |
| D-0742-2021 | Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01; Lot #: 31329295B, exp date. 01/2022 | 2,199 vials | — |
| D-0743-2021 | Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.; Lot #: a) 31329363B, exp. date 01/2022; 31329484B, exp. date 03/2022 b) 31328367B, 31328431B, exp. date 07/2021; 31329014B, exp. date 11/2021 | 50,713 vials | — |
| D-0744-2021 | Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01; Lot #: 31327466B, exp. date 08/2021 | 3,067 vials | — |
| D-0745-2021 | Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01; Lot #: 31329169B, 31329231B, exp. Date 06/2022 | 6,184 vials | — |
| D-0746-2021 | Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01; Lot #: 31325596B, exp. date 08/2021; 31328129B, exp. date 11/2022; 31328356B, exp. date 01/2023; 31329297B, exp. date 06/2023; 31329569B, 31329821B, exp. date 08/2023 | 476,275 vials | — |
| D-0747-2021 | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91; Lot #: 313282585B, exp. date 11/2022 | 42,046 vials | — |
| D-0748-2021 | Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01; Lot #: 100022401, exp. date 04/2023 | 20,800 vials | — |
What to do — step by step
Check Product Details
Look for the NDC code 0703-1995-01 and lot number 31329113B on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed Nationwide, including 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 2.9 years 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-0738-2021 (July 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0738-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.