CLASS I ONGOING Drug recall · Reported 24 Jan 2024 · FDA Enforcement Report
Atropine Sulfate Injection, USP 1 mg/ (0.1 mg/mL) recalled by Pfizer
Pfizer is recalling Atropine Sulfate Injection, USP 1 mg/ (0.1 mg/mL), Lifeshield, Glass Abboject Unit of Use, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 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-0235-2024
- FDA event ID
- 93681
- Recalling firm
- Pfizer, New York, NY
- Brand
- Atropine Sulfate
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Dec 2023
- FDA classified
- 17 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 17 Jan 2024 | Classified by FDA | +27 days |
| 24 Jan 2024 | 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
Presence of Particulate Matter; identified as glass
Product as listed by the FDA
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case).
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; identified as glass
Which lots are affected?
Lot GY2496, Exp 02/01/2025
Where was it sold?
Nationwide in the USA and Puerto Rico.
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.
Other products in this recall event
2 other products · FDA event 93681This product is part of a recall event; the main page for the event is 4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled | Pfizer | Particulate Matter | Nationwide | |
| CLASS I | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Pfizer | Particulate Matter | Nationwide |
More recalls from Pfizer
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Atropine recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atropine Sulfate injection, USP, 1 mg/mL recalled by American RegentAtropine Sulfate | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Atropine Sulfate Injection, USP 8 mg recalled by Accord HealthcareAtropine Sulfate | Accord Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |