CLASS II Drug recall · Reported 20 Jul 2016 · FDA Enforcement Report

Methohexital (Brevital Sodium) 10 mg/mL syringe recalled

Pharmakon Pharmaceuticals is recalling Methohexital (Brevital Sodium) 10 mg/mL syringe, distributed nationwide in the US. The recall was initiated on 20 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Sterile Compounded Products within Expiry

Quantity recalled225

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1274-2016
FDA event ID: 73960
Recalling firm: Pharmakon Pharmaceuticals, Noblesville, IN
Classification: Class II
Status: Terminated
Recall initiated: 20 Apr 2016
FDA classified: 11 Jul 2016
Reported: 20 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Compounded Drugs

Timeline

20 Apr 2016	Recall initiated by company
11 Jul 2016	Classified by FDA	+82 days
20 Jul 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72

Where it was distributed

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Nationwide California Kentucky Maryland North Carolina Oklahoma Texas Virginia

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

All Sterile Compounded Products within Expiry

Where was it sold?

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

87 other products · FDA event 73960

This product is part of a recall event; the main page for the event is Norepinephrine Bitartrate 8mg Added to 5% Dextrose recalled.

Reported	Class	Recall	Company	Reason	Where
20 Jul 2016	CLASS II	Norepinephrine Bitartrate 8mg Added to 5% Dextrose recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Oxytocin added to Lactated Ringers in a lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Norepinephrine 16 mg added to 0.9% sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Diltiazem HCI 250 mg in 5% Dextrose lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Bupivacaine HCI 0.125% fill in a syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Lidocaine 2% syringe recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Promethazine 6.25 mg added to 0.9% Sodium Chloride in B/Braun PAB recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Morphine Sulfate (PF) 0.5mg/mL recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Midazolam (PF) 5mg/ml BD syringe recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Midazolam HCl 1mg/mL in 0.9% Sodium Chloride Intravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Rocuronium 10mg/ml fill in a BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Vancomycin HCL 1.25 GM added to 5% Dextrose in a lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ropivacaine HCI 0.2% in 0.9% Sodium Chloride lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate injection, 50 mcg/mL lntravia IV recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Midazolam HCI 1mg/mL in 0.9% Sodium Chloride fill in a syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 50 mcg/ml injection fill in a syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Morphine Sulfate 1mg/mL (Preserved) recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 2.5 mcg/mL & Bupivacaine recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 50 mcg/mL syringe recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Atropine Sulfate 0.4mg/mL fill in a syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride PCA Vial recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ketamine 2 mg/mL in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Morphine Sulfate (Preserved) 2mg/mL recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Bupivacaine HCI 0.125% in 0.9% Sodium Chloride lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Morphine Sulfate 1 mg/mL in 5% Dextrose lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ceftriaxone 1GM injection in Sterile Water BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ketamine 100mg/mL fill syringe recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Propofol1% 10mg/mL injection BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydromorphone HCl 1mg/ml injection recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Succinylcholine Chloride 20 mg/mL injection syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Vecuronium 1mg/mL in Sterile Water BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Oxytocin added to Lactated Ringers in a lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Cefazolin 2GM added to 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride Cadd recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Promethazine 25 mg added to 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Oxytocin added to Lactated Ringers in a lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Provocholine pre-diluted in 0.9% Sodium Chloride Set II recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride PCA Vial recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride fill in a BD Syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose bag recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ondansetron 2mg/mL fill in a syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride Cadd recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Phenylephrine HCI 40mg/ in 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride in syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 2mcg/mL & Bupivacaine recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Morphine Sulfate (PF) 1mg/mL recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Cefazolin 3GM Added to a 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 5 mcg/mL & Bupivacaine recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Cefazolin 1GM in Sterile Water BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Magnesium Sulfate 50 GM in Lactated Ringers recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	HYDROmorphone 1mg/mL in 0.9% Sodium Chloride fill in a syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Fentanyl Citrate 2mcg/mL & Ropivacaine HCI recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Midazolam HCI1mg/mL in 0.9% Sodium Chloride fill in a lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Oxytocin added to 0.9% Sodium Chloride in a lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Rocuronium 10 mg/mL syringe recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Bupivacaine HCI 0.25% in 0.9% Sodium Chloride Intravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Sufentanil Citrate 0.4mcg/mL & Bupivacaine recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Oxytocin added to 0.9% Sodium Chloride in a lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Promethazine 12.5mg added to 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Cefazolin 2GM added to 5% Dextrose recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ketamine 50mg/mL in 0.9% Sodium Chloride fill in syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Ketamine 20 mg/mL in 0.9% Sodium Chloride lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016	CLASS II	Succinylcholine Chloride 20 mg/mL BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide

More recalls from Pharmakon Pharmaceuticals

All 116

Reported	Class	Recall	Company	Reason	Where
20 Jul 2016Drug	CLASS II	Succinylcholine Chloride 20 mg/mL BD syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Ketamine 20 mg/mL in 0.9% Sodium Chloride lntravia recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride fill recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Ketamine 50mg/mL in 0.9% Sodium Chloride fill in syringe recalled	Pharmakon Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Cefazolin 2GM added to 5% Dextrose recalled by Pharmakon Pharmaceuticals	Pharmakon Pharmaceuticals	Sterility	Nationwide