FDA Recall D-0473-2025
Teva Pharmaceuticals USA, Inc · Parsippany, NJ
Class II Ongoing 356 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
Presence of foreign tablets/capsules.
Recall record
- Recall number
D-0473-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2025-05-23
- Classified by FDA Center
- 2025-06-20
- FDA published
- 2025-07-02
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Firm location
- Parsippany, NJ
Drug identification
- Brand name(s)
- METOCLOPRAMIDE
- Generic name(s)
- METOCLOPRAMIDE
- Manufacturer(s)
- Teva Pharmaceuticals USA, Inc.
- NDC(s)
0093-2203, 0093-2204- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.