CLASS II ONGOING Drug recall · Reported 2 Jul 2025 · FDA Enforcement Report
Metoclopramide Tablets, USP 10 mg recalled by Teva Pharmaceuticals USA
Teva Pharmaceuticals USA is recalling Metoclopramide Tablets, USP 10 mg, distributed nationwide in the US. The recall was initiated on 23 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0473-2025
- FDA event ID
- 96919
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Metoclopramide
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 May 2025
- FDA classified
- 20 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 23 May 2025 | Recall initiated by company | |
| 20 Jun 2025 | Classified by FDA | +28 days |
| 2 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablets/capsules.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign tablets/capsules.
Which lots are affected?
Lot#: 5420094, Exp 09/30/2027
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva Pharmaceuticals USA
All 280| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Metoclopramide recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Injection USP, 10 mg/ (5 mg/mL) single-use vial recalledMetoclopramide | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Metoclopramide Injection USP, 10 mg/ (5 mg/mL) Single-Use Vial recalledMetoclopramide | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Metoclopramide Injection USP, 10 mg/ (5 mg/mL) recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Metoclopramide Injection USP, 10 mg/ (5 mg/mL) Single-Use recalledMetoclopramide | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Metoclopramide Oral Solution, USP 10 mg/ dose cups recalled | VistaPharm | Sterility | Nationwide |