thejoe Leucine, Phenylalanine, Lysine, Methio

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose recalls: 5 FDA reports

Recalls involving Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose. What was wrong with each batch, and how the FDA graded the risk.

5Reports

3Class I

0Ongoing

2016-06-01Most recent

3 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class I	3
Class II	2

By year reported

Year	Reports
2014	3
2015	1
2016	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Class I

CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL

D-0864-2016 · Class I · reported 2016-06-01 · Terminated

Why it was recalled: Presence of Particulate Matter: identified as dried skin.
Product: CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
Where it went: Nationwide and Puerto Rico
How much: 7,436 bags

Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL

D-0428-2015 · Class II · reported 2015-04-08 · Terminated

Why it was recalled: Lack of Assurance of Sterility; increased complaints received for leaks
Product: Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
Where it went: Nationwide and Singapore
How much: 7444 containers

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections,

D-0301-2015 · Class II · reported 2014-12-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Product: Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
Where it went: Nationwide
How much: 7,220 bags

Class I

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2

D-1159-2014 · Class I · reported 2014-03-26 · Terminated

Why it was recalled: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Product: Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.
Where it went: US Nationwide
How much: 7,068 bags

Class I

Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Contai

D-1158-2014 · Class I · reported 2014-03-26 · Terminated

Why it was recalled: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Product: Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.
Where it went: US Nationwide
How much: 14,574 bags

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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