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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Nephron Sterile Injectable Medications Recalled for Lack of Sterility

Agency Publication Date: July 18, 2022
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Summary

Nephron Sterile Compounding Center LLC is recalling 1,616,777 units of various sterile injectable medications due to a lack of assurance of sterility. The recalled products include critical medications such as Morphine Sulfate, Fentanyl Citrate, Epinephrine, and Ketamine HCl, which are used in hospitals and clinics. While no incidents or injuries have been reported to date, the lack of sterility assurance means the products may not be safe for injection. These products were distributed nationwide in pre-filled syringes and IV bags to healthcare facilities.

Risk

Injectable medications must be sterile to prevent serious health risks. If a non-sterile medication is injected into a patient, it can cause severe infections, systemic illness, or life-threatening sepsis. Because these drugs are administered directly into the bloodstream or tissue in clinical settings, any contamination poses a significant safety risk.

What You Should Do

  1. This recall affects 1,616,777 units of various sterile injectable medications manufactured by the Nephron 503B outsourcing facility, including Morphine, Fentanyl, Ketamine, Epinephrine, and others.
  2. Identify recalled products by checking the label for 'Nephron 503B outsourcing facility' along with the specific product name, National Drug Code (NDC), lot number, and expiration date.
  3. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled injectable products immediately and quarantine any remaining stock to prevent further use.
  5. Contact Nephron Sterile Compounding Center LLC or your wholesale distributor to arrange for the return of any unused medication.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe
Variants: 10 mL Pre-Filled Syringe
Lot Numbers:
SU2014A (Exp. 7/2/2022)
NDC:
69374-919-10
Product: 0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes
Variants: 50 mL Pre-Filled Syringe
Lot Numbers:
BH2001A (Exp. 7/15/2022)
BH2002A (Exp. 8/7/2022)
BH2004A (Exp. 8/22/2022)
BH2005A (Exp. 9/2/2022)
BH2006A (Exp. 9/14/2022)
BH2007A (Exp. 9/29/2022)
BH2008A (Exp. 10/3/2022)
BH2010A (Exp. 10/19/2022)
NDC:
69374-970-50
Product: 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes
Variants: 5 mL Prefilled Syringe
Lot Numbers:
BL2007A (Exp. 7/3/2022)
NDC:
69374-947-50
Product: Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags
Variants: 1000 mL Bag
Lot Numbers:
AA2012A (Exp. 07/04/2022)
NDC:
69374-988-10
Product: Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe
Variants: 3 mL Pre-Filled Syringe
Lot Numbers:
AS2001A (Exp. 8/2/2022)
AS2002A (Exp. 8/17/2022)
AS2003A (Exp. 9/3/2022)
NDC:
69374-935-03
Product: Bupivacaine HCl 150 mg, Ketorolac Tromethamine 60 mg, Ketamine HCl 60 mg Injection, 50 mL syringes
Variants: 50 mL Pre-Filled Syringe
Lot Numbers:
BP2001A (Exp. 7/6/2022)
BP2002A (Exp. 7/27/2022)
BP2007A (Exp. 7/3/2022)
NDC:
69374-514-50
Product: EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes
Variants: 10 mL Pre-Filled Syringe
Lot Numbers:
EN2001A (Exp. 7/9/2022)
EN2003A (Exp. 7/18/2022)
EN2004A (Exp. 8/1/2022)
EN2012A (Exp. 9/1/2022)
NDC:
69374-544-10
Product: EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe
Variants: 10 mL Pre-Filled Syringe
Lot Numbers:
EN2007A (Exp. 7/31/2022)
EN2008A (Exp. 8/18/2022)
EN2013A (Exp. 9/11/2022)
EN2014A (Exp. 10/2/2022)
NDC:
69374-925-10
Product: Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags
Variants: 250 mL IV bag
Lot Numbers:
FN2001A (Exp. 7/8/2022)
FN2001B (Exp. 7/8/2022)
FN2002A (Exp. 7/19/2022)
FN2002B (Exp. 7/19/2022)
FN2003A (Exp. 8/24/2022)
FN2003B (Exp. 8/24/2022)
NDC:
69374-523-21
Product: Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes
Variants: 5 mL Pre-Filled Syringe
Lot Numbers:
GL2001A (Exp. 7/15/2022)
NDC:
69374-903-05
Product: Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes
Variants: 3 mL Pre-Filled Syringe
Lot Numbers:
GL2004A (Exp. 8/26/2022)
NDC:
69374-903-30
Product: HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes
Variants: 50 mL Pre-Filled Syringe
Lot Numbers:
HH2002A (Exp. 7/7/2022)
HH2004A (Exp. 8/28/2022)
HH2005A (Exp. 8/11/2022)
HH2007A (Exp. 9/2/2022)
HH2009A (Exp. 9/10/2022)
HH2011A (Exp. 10/17/2022)
NDC:
69374-529-50
Product: HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes
Variants: 30 mL Pre-Filled Syringe
Lot Numbers:
HH2003A (Exp. 7/26/2022)
HH2006A (Exp. 8/22/2022)
NDC:
69374-529-30
Product: HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe
Variants: 30 mL Pre-Filled Syringe
Lot Numbers:
HN2001A (Exp. 7/23/2022)
HN2003A (Exp. 8/19/2022)
HN2004A (Exp. 9/9/2022)
NDC:
69374-559-30
Product: HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes
Variants: 50 mL Pre-Filled Syringe
Lot Numbers:
HN2002A (Exp. 7/26/2022)
NDC:
69374-559-50
Product: Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes
Variants: 5 mL Pre-Filled Syringe
Lot Numbers:
KH2006A (Exp. 7/20/2022)
KH2006B (Exp. 7/20/2022)
KH2012B (Exp. 8/23/2022)
NDC:
69374-982-55
Product: Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes
Variants: 3 mL Pre-Filled Syringe
Lot Numbers:
KH2002A (Exp. 7/5/2022)
NDC:
69374-982-33
Product: Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe
Variants: 1 mL Pre-Filled Syringe
Lot Numbers:
KH2009A (Exp. 8/16/2022)
KH2011A (Exp. 8/24/2022)
KH2013A (Exp. 8/28/2022)
KH2014A (Exp. 9/9/2022)
KH2018A (Exp. 10/7/2022)
KH2020A (Exp. 10/18/2022)
NDC:
69374-511-01
Product: Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe
Variants: 4 mL Pre-Filled Syringe
Lot Numbers:
LB2002A (Exp. 7/12/2022)
LB2004A (Exp. 8/21/2022)
LB2006A (Exp. 9/3/2022)
LB2008A (Exp. 10/6/2022)
NDC:
69374-946-04
Product: Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe
Variants: 5 mL Pre-Filled Syringe
Lot Numbers:
LI2007A (Exp. 9/24/2022)
NDC:
69374-949-05
Product: Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe
Variants: 5 mL Pre-Filled Syringe
Lot Numbers:
LI2004A (Exp. 8/6/2022)
LI2005A (Exp. 8/31/2022)
LI2006A (Exp. 9.21.2022)
LI2008A (Exp. 10/11/2022)
NDC:
69374-985-05
Product: Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe
Variants: 50 mL Pre-Filled Syringe
Lot Numbers:
MS2002A (Exp. 7/2/2022)
MS2003A (Exp. 7/30/2022)
MS2005A (Exp. 7/31/2022)
MS2008A (Exp. 8/23/2022)
MS2013A (Exp. 9/9/2022)
MS2015A (Exp. 9/26/2022)
MS2019A (Exp. 10/14/2022)
NDC:
69374-979-50
Product: Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe
Variants: 30 mL Pre-Filled Syringe
Lot Numbers:
MS2004A (Exp. 7/30/2022)
MS2007A (Exp. 8/23/2022)
MS2012A (Exp. 9/6/2022)
MS2014A (Exp. 9/10/2022)
MS2016A (Exp. 9/29/2022)
MS2018A (Exp. 10/12/2022)
NDC:
69374-979-30
Product: Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe
Variants: 2 mL Pre-Filled Syringe
Lot Numbers:
MS2001A (Exp. 7/2/2022)
MS2006A (Exp. 8/9/2022)
MS2009A (Exp. 8/25/2022)
MS2011A (Exp. 9/3/2022)
MS2017A (Exp. 10/2/2022)
NDC:
69374-979-02
Product: Morphine Sulfate Injection, USP, 1 mg/mL syringe
Variants: 1 mL Pre-Filled Syringe
Lot Numbers:
MS2010A (Exp. 8/26/2022)
NDC:
69374-979-01
Product: del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag
Variants: 1000 mL IV bag
Lot Numbers:
NC2031A (Exp. 7/7/2022)
NC2033A (Exp. 7/12/2022)
NC2034A (Exp. 7/18/2022)
NC2035A (Exp. 7/19/2022)
NDC:
69374-984-10
Product: Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe
Variants: 3 mL Pre-Filled Syringe
Lot Numbers:
NE2002A (Exp. 7/14/2022)
NE2003A (Exp. 7/24/2022)
NE2006A (Exp. 8/1/2022)
NE2007A (Exp. 8/9/2022)
NE2008A (Exp. 8/18/2022)
NE2009A (Exp. 8/27/2022)
NE2012D (Exp. 10/3/2022)
NDC:
69374-932-03
Product: Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe
Variants: 4 mL Pre-Filled Syringe
Lot Numbers:
NE2004A (Exp. 7/26/2022)
NE2010A (Exp. 9/5/2022)
NE2013A (Exp. 10/20/2022)
NDC:
69374-942-04
Product: Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe
Variants: 5 mL Pre-Filled Syringe
Lot Numbers:
NE2005A (Exp. 7/23/2022)
NE2012A (Exp. 10/3/2022)
NE2012B (Exp. 10/3/2022)
NE2012C (Exp. 10/3/2022)
NDC:
69374-902-05
Product: Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag
Variants: 500 mL IV bag
Lot Numbers:
OX2013C (Exp. 7/9/2022)
OX2013E (Exp. 7/9/2022)
NDC:
69374-543-50
Product: Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe
Variants: 10 mL Pre-Filled Syringe
Lot Numbers:
PE2001A (Exp. 7/1/2022)
PE2003A (Exp. 7/12/2022)
PE2013A (Exp. 8/29/2022)
PE2014A (Exp. 10/5/2022)
NDC:
69374-955-10
Product: Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL) syringe
Variants: 10 mL Pre-Filled Syringe
Lot Numbers:
PE2018A (Exp. 10/3/2022)
NDC:
69374-956-10
Product: Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe
Variants: 10 mL Pre-Filled Syringe
Lot Numbers:
PE2004A (Exp. 7/11/2022)
PE2008A (Exp. 7/22/2022)
PE2008B (Exp. 7/22/2022)
PE2008C (Exp. 7/22/2022)
PE2009A (Exp. 8/5/2022)
PE2009B (Exp. 8/5/2022)
PE2009C (Exp. 8/5/2022)
PE2011B (Exp. 8/22/2022)
PE2017C (Exp. 9/14/2022)
PE2019B (Exp. 4/11/2023)
PE2019C (Exp. 4/11/2023)
NDC:
69374-957-10
Product: Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe
Variants: 5 mL Pre-Filled Syringe
Lot Numbers:
RC2003B (Exp. 8/28/2022)
NDC:
69374-924-05
Product: Ropivacaine HCl, Clonidine HCl, Ketorolac Tromethamine Injection, 50 mL syringe
Variants: 50 mL Pre-Filled Syringe
Lot Numbers:
RP2003A (Exp. 7/20/2022)
RP2003B (Exp. 7/20/2022)
NDC:
69374-515-50
Product: 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe
Variants: 50 mL Pre-Filled Syringe
Lot Numbers:
SB2001B (Exp. 1/2/2023)
SB2001C (Exp. 1/2/2023)
SB2003A (Exp. 2/14/2023)
SB2003B (Exp. 2/14/2023)
SB2003C (Exp. 2/14/2023)
SB2004A (Exp. 3/1/2023)
SB2004B (Exp. 3/1/2023)
SB2004C (Exp. 3/1/2023)
SB2005A (Exp. 3/8/2023)
SB2007A (Exp. 3/22/2023)
SB2007B (Exp. 3/22/2023)
SB2008A (Exp. 3/29/2023)
SB2008B (Exp. 3/29/2023)
SB2009A (Exp. 4/5/2023)
SB2009B (Exp. 4/5/2023)
NDC:
69374-214-50
Product: Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe
Variants: 5 mL Pre-Filled Syringe
Lot Numbers:
SC2002A (Exp. 7/9/2022)
SC2004A (Exp. 7/17/2022)
SC2005A (Exp. 8/2/2022)
SC2006A (Exp. 8/16/2022)
SC2007A (Exp. 8/27/2022)
SC2008A (Exp. 9/7/2022)
SC2009A (Exp. 9/14/2022)
SC2010A (Exp. 9/20/2022)
SC2011A (Exp. 10/10/2022)
NDC:
69374-906-05

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90512
Status: Resolved
Manufacturer: Nephron Sterile Compounding Center LLC
Sold By: hospitals; clinics; healthcare facilities
Manufactured In: United States
Units Affected: 37 products (163 bags; 13,340 syringes; 6900 syringes; 1380 syringes; 2315 syringes; 19,060 syringes; 134,385 syringes; 9410 bags; 3690 syringes; 3450 syringes; 22,805 syringes; 12,900 syringes; 18,570 syringes; 3740 syringes; 91,445 syringes; 30,745 syringes; 47,905 syringes; 184,370 syringes; 64,380 syringes; 37,310 syringes; 5495 syringes; 8985 syringes; 43,385 syringes; 4620 syringes; 1765 bags; 59,520 syringes; 10,700 syringes; 64,365 syringes; 1810 bags; 75,630 syringes; 18,930 syringes; 464,265 syringes; 6340 syringes; 2210 syringes; 36,354 syringes; 85,300 syringes; 18,840 syringes)
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.