CLASS II Drug recall · Reported 18 Dec 2019 · FDA Enforcement Report
25% Dextrose Injection, USP (250 mg/mL) Single-dose recalled by Pfizer
Pfizer is recalling 25% Dextrose Injection, USP (250 mg/mL) Single-dose, distributed nationwide in the US. The recall was initiated on 27 Nov 2019 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-0577-2020
- FDA event ID
- 84366
- Recalling firm
- Pfizer, New York, NY
- Brand
- Dextrose
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2019
- FDA classified
- 6 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Nov 2019 | Recall initiated by company | |
| 6 Dec 2019 | Classified by FDA | +9 days |
| 18 Dec 2019 | 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
Labeling: Incorrect or Missing Lot and/or expiration date.
Product as listed by the FDA
25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
Where it was distributed
Nationwide within the United States including Puerto Rico.
Questions about this recall
Is 25% Dextrose Injection, USP (250 mg/mL) Single-dose recalled?
Yes. Pfizer recalled 25% Dextrose Injection, USP (250 mg/mL) Single-dose on 27 Nov 2019. The recall is Class II and its status is Terminated. Recall number D-0577-2020.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or expiration date.
Which lots are affected?
Lot #: 80-292-EV, 1AUG2019 on carton. Expiration date printed on syringe is 1AUG2021 which is incorrect.
Where was it sold?
Nationwide within the United States including 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 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 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 Dextrose Monohydrate recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP ADD-Vantage Unit recalled by PfizerDextrose | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP Viaflex recalled by Baxter HealthcareDextrose | Baxter Healthcare | Foreign Material | Nationwide |