CLASS I Drug recall · Reported 31 Oct 2012 · FDA Enforcement Report
HYDROmorphone HCl Injection, USP, 2 mg/mL fill recalled by Hospira
Hospira is recalling HYDROmorphone HCl Injection, USP, 2 mg/mL fill in a Carpuject prefilled cartridge unit, distributed nationwide in the US. The recall was initiated on 15 Aug 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-020-2013
- FDA event ID
- 62854
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Aug 2012
- FDA classified
- 24 Oct 2012
- Reported
- 31 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 15 Aug 2012 | Recall initiated by company | |
| 24 Oct 2012 | Classified by FDA | +70 days |
| 31 Oct 2012 | 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
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).
Where it was distributed
Nationwide
Questions about this recall
Is HYDROmorphone HCl Injection, USP, 2 mg/mL fill in a Carpuject prefilled cartridge unit recalled?
Yes. Hospira recalled HYDROmorphone HCl Injection, USP, 2 mg/mL fill in a Carpuject prefilled cartridge unit on 15 Aug 2012. The recall is Class I and its status is Terminated. Recall number D-020-2013.
Why was it recalled?
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Which lots are affected?
Lot 12720LL, Exp 12/01/13
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 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 21 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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|---|---|---|---|---|---|
| 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 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 Hydromorphone recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydromorphone Hydrochloride Injection, USP, 50mg/ (10 mg/mL) recalled | Akorn | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl Injection, USP, 10 mg/ 2 mg/mL) syringes recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl Injection, USP, 50 mg/ (1 mg/mL) syringes recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl Injection, USP 30 mg/ (1 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl Injection, USP, 6 mg/ 2 mg/mL) syringes recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |