Teva Initiates Voluntary Nationwide Recall of one (1) Lot of Metoclopramide Tablets USP, 10mg

23 May 2025, Parsippany, NJ. Teva Pharmaceuticals USA, has initiated a voluntary nationwide recall of one (1) lot of Metoclopramide Tablets USP, 10 mg to the Consumer Level. This medication is manufactured by Teva Pharmaceuticals USA under the Teva label. This recall has been initiated as a safety precaution for people who take this medication because a single Torsemide Tablet (20 mg) that does not belong was discovered in each of three individual sealed bottles of Metoclopramide Tablets USP, 10 mg from lot 5420094.

The clinical concern regarding use of medication from any of the bottles from the recalled lot is the possibility of a Torsemide Tablet being ingested and prompting an unintended drug reaction and/or lack of effect for the prescribed medical use of Metoclopramide. To date, Teva has received no relevant complaints for drug ineffectiveness, lack of effect or lack of efficacy. Teva prioritizes patient safety and product quality at every stage of a medicine’s lifecycle. 

Teva’s health hazard assessment concluded that the use of medication from any bottles from the recalled lot of Metoclopramide Tablets potentially presents health risks which could lead to severe adverse health consequences outside the known safety profile of Metoclopramide if a Torsemide Tablet (20 mg) is ingested.  However, the likelihood of an unintended drug reaction occurrence is remote/unlikely as Metoclopramide Tablets will not be dispensed in the original packaging but will be divided at the pharmacy level and be dispensed in smaller quantities for patient use, where the difference in tablets is likely to be noticed by the pharmacist.

NDC#	Lot	Exp. Date	Strength	Size
0093-2203-01	5420094	09/2027	10 mg	100 count bottle

Indications for Metoclopramide Tablets include: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy and for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Teva notified its customers, alerting them that the lot was recalled and requesting that they return impacted product. Instructions for returning recalled product and receiving a credit are given in the Recall letter and Consumer recall letter released by Teva.

Consumers with questions or concerns should first consult with their health care provider(s). To report an Adverse Event or Quality Complaint, or if you have Medical Related Questions, please use the following contact information:

Medical-related Questions or to report an Adverse Event: Contact Medical Information at: 888-838-2872, option 3, then option 4 or USMedInfo@tevapharm.com Live calls received: M - F, 9:00 AM - 5:00 PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week

Product Quality Complaint-related Questions: Contact Quality Assurance Services: 888-838-2872, option 4 Live calls received: M - F, 9:00 AM - 5:00 PM Eastern Time; Voicemail: 24 hrs./day, 7 days/week

Adverse events or other problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.  To complete and submit the report online, please visit: fda.gov/medwatch/report.htm

To complete and submit the report via Regular Mail or Fax:

Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-1088.

This recall was made with the knowledge of the U.S. Food and Drug Administration. Teva will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation.

Description of Metoclopramide Tablets USP, 10 mg recalled:

To help identify the drug product that is the subject of the recall, a description of the Metoclopramide Tablets is found below:  white, round, scored tablets, debossed with “TEVA” on one side and “2203” above the score on the other side of the tablet (re: Table 1).

Table 1 Metoclopramide Tablets USP, 10 mg

Image Shown Has Not Been Reproduced to Scale of Actual