CLASS II Drug recall · Reported 26 May 2021 · FDA Enforcement Report
Sterile Water for Inj., USP, mL Single Dose Vials recalled by Pfizer
Pfizer is recalling Sterile Water for Inj., USP, mL Single Dose Vials per, distributed nationwide in the US. The recall was initiated on 3 May 2021 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-0384-2021
- FDA event ID
- 87831
- Recalling firm
- Pfizer, New York, NY
- Brand
- Sterile Water
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 May 2021
- FDA classified
- 14 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 3 May 2021 | Recall initiated by company | |
| 14 May 2021 | Classified by FDA | +11 days |
| 26 May 2021 | Published in enforcement report | +12 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: particulate matter identified as an insect in one vial.
Product as listed by the FDA
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Which lots are affected?
Lot DN9185
Where was it sold?
Nationwide USA
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.
More recalls from Pfizer
All 129| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalledLevoxyl | Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalledLevoxyl | Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
Other Water recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Water for Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | Sterile Water for Irrigation, Single-Dose recalled by Baxter HealthcareSterile Water | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Sterile Water For Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | Sterile Water for Injection, USP, mL Single-Dose Vials recalled | Nephron Sc | Manufacturing (CGMP) Deviations | SC |
| Drug | CLASS II | Sterile Water for Injection recalled by Nephron Sc | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |