May 2025 FDA Recall Metoclopramide by Teva Pharmaceuticals Usa, Inc
D-0473-2025 - Presence of foreign tablets/capsules.
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on May 23, 2025 for the product Metoclopramide. The FDA reported the reason for recall as presence of foreign tablets/capsules.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0473-2025
Presence of foreign tablets/capsules.
05-23-2025
07-02-2025
36612 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
Batch or Lot Expiration Information
Lot# : 5420094, Exp 09/30/2027
