CLASS II Drug recall · Reported 27 Mar 2013 · FDA Enforcement Report
METRONIDazole Injection, USP 500 mg (5 mg/mL) recalled by Hospira
Hospira is recalling METRONIDazole Injection, USP 500 mg (5 mg/mL), distributed nationwide in the US. The recall was initiated on 15 Feb 2013 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-206-2013
- FDA event ID
- 64482
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2013
- FDA classified
- 21 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 15 Feb 2013 | Recall initiated by company | |
| 21 Mar 2013 | Classified by FDA | +34 days |
| 27 Mar 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Which lots are affected?
Lot code 12-074-JT Exp 12/13
Where was it sold?
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.
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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 |