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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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Showing 3,601–3,620 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-902-05

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-942-04

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-932-03

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-01

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-02

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-511-01

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
June 30, 2022
Reported by FDA
July 27, 2022
Distribution
Nationwide in the USA

View recall →

Data last updated:

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.