thejoe Pharmakon Pharmaceuticals

Pharmakon Pharmaceuticals: 28 FDA recall reports

Every drug recall the FDA has published for Pharmakon Pharmaceuticals. The fault, and how the agency graded it.

28Reports

5Class I

0Ongoing

2016-06-01Most recent

5 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 II	23
Class I	5

By year reported

Year	Reports
2014	5
2016	23

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

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compo

D-0871-2016 · Class I · reported 2016-06-01 · Terminated

Why it was recalled: Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Product: Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
Where it went: IN and IL
How much: 75 Syringes

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in

D-0609-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: N/A

Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals,

D-0602-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 250

Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx

D-0588-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 4123

Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5m

D-0590-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: N/A

Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceutical

D-0600-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 600

Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx

D-0595-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 665

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syrin

D-0606-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: N/A

Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceutical

D-0591-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 5875

Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx

D-0593-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Subpotent drug.
Product: Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 210

Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

D-0594-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 4100

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx o

D-0598-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 8000

Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmace

D-0592-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 2750

Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx

D-0589-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Subpotent drug.
Product: Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 1150

Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1

D-0597-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 475

Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 1

D-0596-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 7100

Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Ph

D-0604-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 400

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syri

D-0605-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 378

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in sy

D-0608-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: N/A

Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHA

D-0603-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 5000

Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceut

D-0599-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 1530

Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1

D-0601-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: 525

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syrin

D-0607-2016 · Class II · reported 2016-02-03 · Terminated

Why it was recalled: Stability data does not support expiry.
Product: Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it went: Nationwide
How much: N/A

Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd.,

D-1567-2014 · Class II · reported 2014-09-03 · Terminated

Why it was recalled: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Product: Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
Where it went: United States: TX, IL, MD, IN
How much: 200 Syringes

Class I

Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14

D-1565-2014 · Class I · reported 2014-09-03 · Terminated

Why it was recalled: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Product: Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
Where it went: United States: TX, IL, MD, IN
How much: 20 vials

Class I

Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmako

D-1566-2014 · Class I · reported 2014-09-03 · Terminated

Why it was recalled: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Product: Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
Where it went: United States: TX, IL, MD, IN
How much: 10/50 mL bags, 40/100 mL bags

Class I

Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Ph

D-1568-2014 · Class I · reported 2014-09-03 · Terminated

Why it was recalled: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Product: Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
Where it went: United States: TX, IL, MD, IN
How much: 5 Syringes

Class I

Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmac

D-1362-2014 · Class I · reported 2014-06-18 · Terminated

Why it was recalled: Superpotent Drug: Product contains twice the stated amount of midazolam.
Product: Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.
Where it went: IN
How much: 80 syringes

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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