thejoe Pharmakon Pharmaceuticals, Inc.

Pharmakon Pharmaceuticals, Inc.: 88 FDA recall reports

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

88Reports

0Class I

0Ongoing

2016-07-20Most recent

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	88

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.

Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceutical

D-1303-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 70

Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmac

D-1297-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 72

Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceutica

D-1272-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 24

Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, No

D-1309-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 10

Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nobles

D-1288-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 40

Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 451

D-1332-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 50

Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceutica

D-1266-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 400

HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only,

D-1325-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 90

Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceutica

D-1301-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 1200

Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHA

D-1273-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 40

Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHA

D-1281-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 25

Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 4606

D-1267-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 40

HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by P

D-1305-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 560

Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuti

D-1341-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 10

Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesvil

D-1339-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 1200

Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceutic

D-1330-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 800

Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHA

D-1312-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 675

Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmac

D-1318-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 216

Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuti

D-1331-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 129

Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals,

D-1263-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 200

Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceutic

D-1257-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 130 bags

Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compound

D-1269-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 95

Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuti

D-1338-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 2000

Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuti

D-1259-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0100-69
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 4050 syringes

Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounde

D-1283-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 20

Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Phar

D-1316-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 300

Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHAR

D-1324-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 2735

Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compound

D-1308-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 260

Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 460

D-1337-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 1500

Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nob

D-1313-2016 · Class II · reported 2016-07-20 · Terminated

Why it was recalled: Lack of Assurance of Sterility
Product: Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71
Where it went: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
How much: 400

Showing the 30 most recent of 88. The rest are searchable at the FDA enforcement report database.

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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