CLASS I Drug recall · Reported 24 Apr 2013 · FDA Enforcement Report
Lactated Ringer's and 5% Dextrose Injection, USP flexible containers recalled
Hospira is recalling Lactated Ringer's and 5% Dextrose Injection, USP flexible containers, distributed nationwide in the US. The recall was initiated on 5 Oct 2012 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-263-2013
- FDA event ID
- 63432
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Oct 2012
- FDA classified
- 17 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Mold
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Oct 2012 | Recall initiated by company | |
| 17 Apr 2013 | Classified by FDA | +194 days |
| 24 Apr 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Product as listed by the FDA
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Which lots are affected?
Lot # :12-160-JT*, Exp 12/01/13; lot number * may be followed by 01 or 90
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 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.
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Lactated Ringer's recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Lactated Ringer's Injection, USP flexible container recalled | ICU Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection, USP flexible container recalled | ICU Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's and 5% Dextrose Injection USP, flexible containers recalled | Hospira | Mold | Nationwide |
| Drug | CLASS II | Lactated Ringer's and 5% Dextrose Injection recalled by Hospira | Hospira | Sterility | Nationwide |
| Drug | CLASS II | Lactated Ringer's Injection, USP container recalled by Hospira | Hospira | Sterility | Nationwide |