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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

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

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

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

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass II

Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72

by Pharmakon Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: April 20, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

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Drug Recall Terminated Historical recordClass III

DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10

by Golden State Medical Supply Inc.

Reason: Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Recall initiated: June 28, 2016
Reported by FDA: July 20, 2016
Distribution: Nationwide. No foreign distribution.

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Drug Recall Terminated Historical recordClass II

HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

by Medaus, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: May 13, 2016
Reported by FDA: July 20, 2016
Distribution: U.S. Nationwide, Japan, and New Zealand.

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Drug Recall Terminated Historical recordClass II

ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY

by Medaus, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: May 13, 2016
Reported by FDA: July 20, 2016
Distribution: U.S. Nationwide, Japan, and New Zealand.

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Drug Recall Terminated Historical recordClass II

ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

by Medaus, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: May 13, 2016
Reported by FDA: July 20, 2016
Distribution: U.S. Nationwide, Japan, and New Zealand.

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Drug Recall Terminated Historical recordClass II

ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY

by Medaus, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: May 13, 2016
Reported by FDA: July 20, 2016
Distribution: U.S. Nationwide, Japan, and New Zealand.

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Drug Recall Terminated Historical recordClass II

ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY

by Medaus, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: May 13, 2016
Reported by FDA: July 20, 2016
Distribution: U.S. Nationwide, Japan, and New Zealand.

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Drug Recall Terminated Historical recordClass II

TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY

by Medaus, Inc.

Reason: Lack of Assurance of Sterility
Recall initiated: May 13, 2016
Reported by FDA: July 20, 2016
Distribution: U.S. Nationwide, Japan, and New Zealand.

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Data last updated: September 26, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.