CLASS I Drug recall · Reported 13 Jun 2018 · FDA Enforcement Report
Naloxone Hydrochloride Injection, USP, 4 mg/mL recalled
Hospira Inc, Lake Forest is recalling Naloxone Hydrochloride Injection, USP, 4 mg/mL in Carpuject Single-use cartridge syringe, distributed nationwide in the US. The recall was initiated on 4 Jun 2018 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-0906-2018
- FDA event ID
- 80167
- Recalling firm
- Hospira Inc, Lake Forest, LAKE FOREST, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Jun 2018
- FDA classified
- 2 Jul 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Jun 2018 | Recall initiated by company | |
| 13 Jun 2018 | Published in enforcement report | +9 days |
| 2 Jul 2018 | Classified by FDA | +19 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; Potential for particulate matter on the syringe plunger.
Product as listed by the FDA
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL
Where it was distributed
Nationwide in the U.S., Puerto Rico, and Guam
Questions about this recall
Is Naloxone Hydrochloride Injection, USP, 4 mg/mL in Carpuject Single-use cartridge syringe recalled?
Yes. Hospira Inc, Lake Forest recalled Naloxone Hydrochloride Injection, USP, 4 mg/mL in Carpuject Single-use cartridge syringe on 4 Jun 2018. The recall is Class I and its status is Terminated. Recall number D-0906-2018.
Why was it recalled?
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Which lots are affected?
72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)
Where was it sold?
Nationwide in the U.S., Puerto Rico, and Guam
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.
More recalls from Hospira Inc, Lake Forest
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydromorphone Hydrochloride Injection, USP, 50 mg recalledHydromorphone Hydrochloride | Hospira Inc, Lake Forest | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydromorphone Hydrochloride Injection, USP, 500 mg recalledHydromorphone Hydrochloride | Hospira Inc, Lake Forest | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydromorphone Hydrochloride Injection, USP, 500 mg recalledHydromorphone Hydrochloride | Hospira Inc, Lake Forest | Particulate Matter | Nationwide |
Other Naloxone recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naloxone Injection, USP 4 mg/mL, For Intravenous recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box recalledNarcan | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |