Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported September 22, 2021
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Icu Medical Inc recalled AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx… - a critical-severity action.
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx… was recalled by Icu Medical Inc in September 22, 2021. Reason: Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material alo…. Check the official notice for the remedy. Verify recall #D-0805-2021 with the FDA Drug before acting.
The recall
Icu Medical Inc issued this critical-severity FDA Drug recall-Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material alo….
- Critical
- severity level
- Class I
- classification
- September 22, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0805-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0805-2021) was formally reported on September 22, 2021, with the manufacturer initiating the action on September 3, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Icu Medical Inc is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 2,112 Flexible Containers.
The documented reason for this recall is: Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples. Distribution data in the federal record shows the product reached: Distributed Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,112 Flexible Containers
Related Recalls
6
5 from same agency
Product description
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
Reason for recall
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0805-2021 |
| Date reported | September 22, 2021 |
| Date initiated | September 3, 2021 |
| Recalling firm | Icu Medical Inc |
| Firm location | Lake Forest, IL |
| Affected scope | 2,112 Flexible Containers |
| Distribution | Distributed Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0805-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17. Recalled by Icu Medical Inc. Units affected: 2,112 Flexible Containers.
Why was this product recalled? ▼
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 22, 2021. Severity: Critical. Recall number: D-0805-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0805-2021) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Low
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Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bot…
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Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
FDA Drug Moderate
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
Lupin Pharmaceuticals Inc. · 2026-05-27
Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported September 22, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.