Hospira Recalls Propofol Injectable Emulsion Due to Visible Particulate Matter
Hospira Inc. is recalling 68,020 vials of Propofol Injectable Emulsion, 1%, due to the presence of visible particulate matter.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (injectable drug) where the hazard is particulate matter, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Hospira Inc. is recalling 68,020 vials of Propofol Injectable Emulsion, 1%, packaged in single-patient infusion vials. The recall is being conducted because visible particulate matter was observed and confirmed in a sample bottle during a retain inspection.
The affected product is distributed nationwide. The specific lots involved are 06-804-DJ* (expiration 1JUN2013), 05-736-DJ* (expiration 1MAY2013), and 09-066-DJ* (expiration 1SEP2013). The lot numbers may be followed by 01 or 02. The product is available in two configurations: 5 x 20 mL vials per carton (NDC 0409-4699-30) and 10 x 100 mL vials per carton (NDC 0409-4699-24).
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions. This recall is classified as FDA Class II.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 68,020
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- a) Lot #: 06-804-DJ*
- Exp 1JUN2013
- and b) Lot #: 05-736-DJ*
- Exp 1MAY2013
- 09-066-DJ*
- Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PROPOFOL
- CriticalPropofol Injectable Emulsion Recalled for Particulate Matter Contamination
FDA (Drugs) · 2022-09-21
- SeverePropofol Injectable Emulsion Vials Recalled for Particulate Matter Contamination
FDA (Drugs) · 2022-08-03
- SevereHospira Recalls Propofol Injectable Emulsion Due to Temperature Excursions
FDA (Drugs) · 2015-02-25
- SevereHospira Recalls Propofol Injectable Vials Due to Embedded Particulate Matter
FDA (Drugs) · 2015-02-04
- SevereHospira Recalls Propofol Vials Due to Metallic Particulate Matter
FDA (Drugs) · 2014-08-27
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereAmerican Regent Recalls Atropine Sulfate Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereFDA Recalls Nicardipine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Multrys Trace Elements Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26