CLASS I ONGOING Drug recall · Reported 24 Jan 2024 · FDA Enforcement Report
Atropine Sulfate Injection, USP 1 mg/ 1 mg/mL), Lifeshield recalled
Pfizer is recalling Atropine Sulfate Injection, USP 1 mg/ 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
Is Atropine Sulfate Injection, USP 1 mg/ 1 mg/mL), Lifeshield, Glass Abboject Unit of Use recalled?
Yes. Pfizer recalled Atropine Sulfate Injection, USP 1 mg/ 1 mg/mL), Lifeshield, Glass Abboject Unit of Use on 21 Dec 2023. The recall is Class I and its status is Ongoing. Recall number D-0235-2024.
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 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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Other Atropine recalls
All 11| 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 II | Atropine Sulfate Injection, USP 8 mg per 4 mg per mL) recalledAtropine Sulfate | Accord Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Injection, USP 2 mg/ 4 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Isopto Atropine (atropine sulfate ophthalmic solution) recalledIsopto Atropine | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Atropine Sulfate Injection, 8 mg/ 4 mg/mL) Single Dose Syringe recalled | SCA Pharmaceuticals | Sterility | Nationwide |