CLASS II Drug recall · Reported 12 Oct 2022 · FDA Enforcement Report
Aminophylline Injection, USP 250 mg/ (25 mg/mL) mL Single-dose vial recalled
Pfizer is recalling Aminophylline Injection, USP 250 mg/ (25 mg/mL) mL Single-dose vial, distributed in Puerto Rico. The recall was initiated on 27 Sep 2022 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-0003-2023
- FDA event ID
- 90903
- Recalling firm
- Pfizer, New York, NY
- Brand
- Aminophylline
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2022
- FDA classified
- 4 Oct 2022
- Reported
- 12 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Sep 2022 | Recall initiated by company | |
| 4 Oct 2022 | Classified by FDA | +7 days |
| 12 Oct 2022 | Published in enforcement report | +8 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: A complaint was received for the presence of a hair in one vial.
Product as listed by the FDA
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
Where it was distributed
Distributed in the United States and Puerto Rico.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Which lots are affected?
Lot: 30-137-DK Exp. 1 DEC. 2022
Where was it sold?
Distributed in the United States 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 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.
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| 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 Aminophylline recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aminophylline 25mg/ml, Main Street Compounding Pharmacy recalled | Main Street Family Pharmacy | Other | Nationwide |
| Drug | CLASS II | Aminophylline 250mg, Main Street Compounding Pharmacy recalled | Main Street Family Pharmacy | Other | Nationwide |
| Drug | CLASS II | Aminophylline 2.5% Injection recalled by Lowlite Investments | Lowlite Investments | Sterility | Nationwide |
| Drug | CLASS II | Aminophylline, Sdv** 500mg (25mg/ML) Injectable (1 Product) recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |