Teva Pharmaceuticals USA recalls Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva
Teva recalls 10-vial Haloperidol Decanoate injection due to potential lack of sterility. This could cause infections if used improperly. Consumers should contact Teva for details.
Use caution until it’s fixed
Lack of Assurance of Sterility
Contact the company & request your remedy
What happened, in plain English
Teva is recalling 10-vial Haloperidol Decanoate injection products because they may not be sterile. Using these injections could lead to infections, especially in medical settings where sterility is critical. Read more at govinfonow.com/recall/36198-teva-haloperidol-decanoate-injection-recall-lack-of-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36198-teva-haloperidol-decanoate-injection-recall-lack-of-sterility-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0375-2021
Cite this page
“Teva Haloperidol Decanoate Injection Recall: Lack of Sterility Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36198-teva-haloperidol-decanoate-injection-recall-lack-of-sterility-risk. Based on FDA recall #D-0375-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0375-2021%22&limit=1).
Why it’s dangerous
The injection vials may not be sterile, which can lead to infections if the product is used without proper sterilization. This is particularly dangerous in medical settings where contamination could cause serious health issues.
Who’s affected
Prescription patients using this medication for psychiatric conditions. Healthcare providers administering the injection are at higher risk due to the sterile nature of the product.
How to tell if you have this one
Check for the product name 'Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials' with NDC 00703-7121-03 and lot number 31325793C. The expiration date is September 2021.
- Brand
Teva- Category
Drug
All 5 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.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0374-2021 | Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.); NDC 0703-5145-01: Lot # 31325332B, exp. date 08/2021, Lot # 31325756B, exp. date 09/2021 AND NDC 0703-5145-91: Lot # 31325685B, exp. date 09/2021 | 192,277 cartons/1 single dose vial per carton | — |
| D-0375-2021 | Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03; Lot # 31325793C, exp. date 09/2021 | 3150 vials | — |
| D-0376-2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01; Lot # 31327989B, exp. date 04/2021 | 7,564/1 multiple dose vial per carton | — |
| D-0377-2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04; Lot # 31325459B, exp. date 08/2021 | 3,138/25 single use vials per tray | 0703-4502-01, 0703-4502-04 |
| D-0378-2021 | Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03; Lot # 31325394C, exp. date 09/2021 Lot # 31327161B, exp. date 04/2022 | 7020 vials | — |
What to do — step by step
Contact Teva
Reach out to Teva Pharmaceuticals USA for specific instructions on handling the recalled product.
Questions people ask
Is this product safe to use?
The recall indicates a potential lack of sterility, so it is not safe to use without contacting Teva for guidance.
How can I check if I have the recalled product?
Look for the NDC code 00703-7121-03 and lot number 31325793C on the vial label.
What should I do if I have the recalled product?
Contact Teva Pharmaceuticals USA for specific instructions on handling the recalled product.
Contact Teva
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0375-2021 — Teva Teva Hello, I own a Teva that is covered by recall D-0375-2021 from Teva. 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-0375-2021 (April 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0375-2021 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.