Stop using nowDrug recall · FDA · Published September 3, 2021
ICU Medical AMINOSYN II 15% Injection Recall: Particulate Matter Hazard
ICU Medical recalls AMINOSYN II 15% amino acid injection due to particulate matter found in samples. This could cause serious issues for patients receiving the injection.
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Take action
Contact the company
📍Recalling firmICU Medical Inc600 N Field Dr · Lake Forest, IL 60045-4835
“ICU Medical AMINOSYN II 15% Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35863-icu-medical-aminosyn-ii-15-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0805-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0805-2021%22&limit=1).
The FDA announced on Sept. 3, 2021, that ICU Medical Inc. is recalling AMINOSYN II 15% An Amino Acid Injection due to the presence of particulate matter including fibers and hair. The Class I recall affects 2,112 flexible containers distributed nationwide.
How to tell if you have it
Brand: ICU Medical
Product: AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers
NDC: 0409-7171-17
Lot: 4989094
Expiration: 01-APR-2022
Manufacturer: Hospira, Inc., Lake Forest, IL 60045
The hazard
The recall cites the presence of particulate matter identified as fibers, hair, and proteinaceous material along with other particles found in retained samples. The FDA classified this as a Class I recall, indicating a high risk of adverse health consequences.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Recent brand recalls include the Aug. 20, 2026 ICU Medical CADD Yellow Medication Cassette Reservoir Recall and the June 24, 2026 ICU Medical Hotline Fluid Warming Set Recall. Other recent recalls of similar products include American Regent Aminocaproic Acid Injection Recall (July 24, 2026), B. Braun Medical Lactated Ringer's Injection Recall (Aug. 12, 2026), and GE Healthcare Omnipaque 300 mg/mL Injection Recall (March 24, 2026).
How to tell if you have this one
Check for the product name 'AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL' in flexible containers. The lot number 4989094 with expiration date 01-APR-2022 is associated with this recall.
Brand
ICU Medical
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the recalled AMINOSYN II 15% injection if you have it.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-0805-2021 (September 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0805-2021 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.