CLASS I Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
Metronidazole Injection USP, 500 mg recalled by Baxter Healthcare
Baxter Healthcare is recalling Metronidazole Injection USP, 500 mg per (5 mg/mL) Sterile Single Dose Container, distributed nationwide in the US. The recall was initiated on 21 Jan 2016 and the FDA has classified it as Class I.
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-0863-2016
- FDA event ID
- 73118
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Metronidazole
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Jan 2016
- FDA classified
- 23 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Antibiotics
Timeline
| 21 Jan 2016 | Recall initiated by company | |
| 23 May 2016 | Classified by FDA | +123 days |
| 1 Jun 2016 | Published in enforcement report | +9 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 Particulate Matter: identified as a cloth fiber.
Product as listed by the FDA
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: identified as a cloth fiber.
Which lots are affected?
Lot #: P339135, Exp 08/31/2017
Where was it sold?
Nationwide and Puerto Rico
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
3 other products · FDA event 73118| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | 0.9% Sodium Chloride Injection recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Particulate Matter | Nationwide | |
| CLASS II | 0.9% Sodium Chloride Injection recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Sterility | Nationwide | |
| CLASS I | Clinimix E 5/15 sulfite-free (5% Amino Acid recalledClinimix E | Baxter Healthcare | Particulate Matter | Nationwide |
More recalls from Baxter Healthcare
All 573| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Metronidazole recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metronidazole 500MG, antibiotic recalled by Sentara Infusion Services | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Metronidazole Vaginal Gel USP, 0.75% with 5 applicators recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metronidazole tablets, USP 250 mg unit dose recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metronidazole 500mg Tablet recalled by Safecor Health | Safecor Health | Manufacturing (CGMP) Deviations | MA, NY |
| Drug | CLASS II | Metronidazole Injection, USP, 500 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide |