Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: May 14, 2021
Share:
Sign in to monitor this recall

Summary

Teva Pharmaceuticals USA is recalling approximately 213,149 units of several injectable medications, including Leucovorin Calcium, Haloperidol Decanoate, Methylprednisolone Acetate, and Metoclopramide. These products are being recalled because the company cannot guarantee they are sterile, which is a critical safety requirement for injected drugs. Consumers who have received these medications should be aware that the recall affects multiple lot numbers distributed nationwide.

Risk

A lack of sterility assurance in injectable medications can lead to serious systemic infections or localized site reactions if the product is contaminated with bacteria or fungi. While no specific injuries or infections have been reported in this notice, the risk is elevated because these drugs are administered directly into the body via intramuscular or intravenous injection.

What You Should Do

  1. Check your medication vials and packaging for the following affected products and lot numbers: Leucovorin Calcium 350 mg (Lot 31325332B, 31325756B, 31325685B), Haloperidol Decanoate 50 mg/mL (Lot 31325793C), Methylprednisolone Acetate 40 mg/mL (Lot 31327989B), Metoclopramide 10 mg/2 mL (Lot 31325459B), and Haloperidol Decanoate 100 mg/mL (Lot 31325394C, 31327161B).
  2. Verify the National Drug Code (NDC) on the label: Leucovorin (0703-5145-01, 0703-5145-91), Haloperidol 50mg (00703-7121-03), Methylprednisolone (0703-0045-01), Metoclopramide (0703-4502-04), or Haloperidol 100mg (0703-7131-03).
  3. If you have an affected lot, stop using the medication immediately and do not administer any remaining doses.
  4. Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to report any adverse health effects you may have experienced.
  5. Return any unused portions of the recalled medication to the pharmacy where it was purchased for a refund and contact Teva Pharmaceuticals USA at 1-888-838-2872 for further instructions.
  6. For additional questions or to report a safety concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and Healthcare Consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Leucovorin Calcium for Injection, 350 mg/vial (20 mg/mL)
Model:
NDC 0703-5145-01
NDC 0703-5145-91
Lot Numbers:
31325332B (Exp 08/2021)
31325756B (Exp 09/2021)
31325685B (Exp 09/2021)
Date Ranges: 08/2021, 09/2021
Product: Haloperidol Decanoate Injection, USP 50 mg/mL (1 mL Single Dose Vial)
Model:
NDC 00703-7121-03
Lot Numbers:
31325793C (Exp 09/2021)
Date Ranges: 09/2021
Product: Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL (10 mL Multiple Dose Vial)
Model:
NDC 0703-0045-01
Lot Numbers:
31327989B (Exp 04/2021)
Date Ranges: 04/2021
Product: Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL) (2 mL Single-Use Vial)
Model:
NDC 0703-4502-04
Lot Numbers:
31325459B (Exp 08/2021)
Date Ranges: 08/2021
Product: Haloperidol Decanoate Injection, USP 100 mg/mL (1 mL Single Dose Vial)
Model:
NDC 0703-7131-03
Lot Numbers:
31325394C (Exp 09/2021)
31327161B (Exp 04/2022)
Date Ranges: 09/2021, 04/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87875
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Hospitals; Pharmacies; Clinics
Manufactured In: United States
Units Affected: 5 products (192,277 cartons/1 single dose vial per carton; 3150 vials; 7,564/1 multiple dose vial per carton; 3,138/25 single use vials per tray; 7020 vials)
Distributed To: Nationwide
Agency Last Updated: May 26, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.