Recalls / Class II
Class IID-0473-2025
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.
- Brand name
- Metoclopramide
- Generic name
- Metoclopramide
- Active ingredient
- Metoclopramide Hydrochloride
- Route
- Oral
- NDCs
- 0093-2203, 0093-2204
- FDA application
- ANDA070184
- Affected lot / code info
- Lot#: 5420094, Exp 09/30/2027
Why it was recalled
Presence of foreign tablets/capsules.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 36612 cartons
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-05-23
- FDA classified
- 2025-06-20
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0473-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.