Lower riskDrug recall · FDA · Published September 27, 2022
Pfizer Aminophylline Injection Recall: Hair Found in Vial
Pfizer recalls aminophylline injection vials due to a hair complaint in one vial. This medication is prescription-only and distributed by Hospira. Check your vial's lot number and NDC code for affected products.
“Pfizer Aminophylline Injection Recall: Hair Found in Vial.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34313-pfizer-aminophylline-injection-recall-hair-found-in-vial. Based on FDA recall #D-0003-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0003-2023%22&limit=1).
The FDA announced on September 27, 2022, that Pfizer Inc. is recalling Aminophylline Injection due to the presence of particulate matter, specifically a hair found in one vial. This Class II recall affects 103,150 single-dose vials distributed by Hospira, Inc.
The recall was initiated after a complaint was received regarding the presence of a hair in one vial of Aminophylline Injection, USP. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Pfizer Inc. has 71 other recalls on record since November 26, 2012. Other recent recalls include Pfizer's August 4, 2025, Sodium Bicarbonate Injection recall for lack of sterility assurance and its July 10, 2025, Bicillin L-A injectable recall due to particulate risk. Similar recent recalls of similar products include Fresenius Kabi's July 16, 2026, Xylocaine 1% Injection recall for hair found in products and its same-day Glycopyrrolate Injection recall for the same issue.
How to tell if you have this one
Check for vials with NDC code 0409-5921-16 (vial) or 0409-5921-01 (carton). The lot number is 30-137-DK and expires December 1, 2022.
Brand
Pfizer
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Details
Look for the NDC code 0409-5921-16 on the vial and 0409-5921-01 on the carton.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed in the United States and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0003-2023 (September 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0003-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.