CLASS II Drug recall · Reported 27 Jul 2022 · FDA Enforcement Report

Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) syringe recalled

Nephron Sterile Compounding Center is recalling Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) syringe, distributed nationwide in the US. The recall was initiated on 30 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: LB2002A, Exp. 7/12/2022; LB2004A, Exp. 8/21/2022; LB2006A, Exp. 9/3/2022; LB2008A, Exp. 10/6/2022

Quantity recalled184,370 syringes

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-1262-2022
FDA event ID: 90512
Recalling firm: Nephron Sterile Compounding Center, West Columbia, SC
Classification: Class II
Status: Terminated
Recall initiated: 30 Jun 2022
FDA classified: 18 Jul 2022
Reported: 27 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

30 Jun 2022	Recall initiated by company
18 Jul 2022	Classified by FDA	+18 days
27 Jul 2022	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

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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lots: LB2002A, Exp. 7/12/2022; LB2004A, Exp. 8/21/2022; LB2006A, Exp. 9/3/2022; LB2008A, Exp. 10/6/2022

Where was it sold?

Nationwide in the USA

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

36 other products · FDA event 90512

This product is part of a recall event; the main page for the event is Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) syringe recalled.

Reported	Class	Recall	Company	Reason	Where
27 Jul 2022	CLASS II	Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Bupivacaine HCl 150 mg (3.0 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	8.4% Sodium Bicarbonate Injection, USP (84 mg/mL) 1 mEq/mL syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Morphine Sulfate Injection, USP, 30 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Ketamine HCl Injection, USP, 50 mg/ (10 mg/mL*) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Glycopyrrolate Injection, USP, 0.6 mg/ (0.2 mg/mL) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	HYDROmorphone HCl Injection, USP, 6 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Neostigmine Methylsulfate Injection, USP, 4 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Fentanyl Citrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Phenylephrine HCl Injection, USP, 0.4 mg/ (40 mcg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Amino Acid Injection (50 mg/mL) recalled by Nephron Sterile Compounding	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Morphine Sulfate Injection, USP, 1 mg/mL syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Phenylephrine HCl Injection, USP, 1 mg/ (100 mcg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Rocuronium Bromide Injection, 50 mg/ (10 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Ketamine HCl Injection, USP 30 mg/ (10 mg/mL*) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Neostigmine Methylsulfate Injection, USP, 5 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Morphine Sulfate Injection, USP, 2 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	HYDROmorphone HCl Injection, USP 30 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Atropine Sulfate Injection, USP 1.2 mg/ (0.4 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Morphine Sulfate Injection, USP, 50 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Glycopyrrolate Injection, USP, 1 mg/ (0.2 mg/mL) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	HYDROmorphone HCl Injection, USP, 50 mg/ (1 mg/mL) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	0.125% Bupivacaine HCl Injection, USP, 62.5 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg/ (80 mcg/mL)syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	HYDROmorphone HCl Injection, USP, 10 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	del Nido Cardioplegia Solution Single-Dose Container IV, IV recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	EPINEPHrine Injection, USP, 0.1 mg/ (10 mcg/mL) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Lidocaine HCl Injection, USP 2%, 100 mg/ (20 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Oxytocin/mL) in 0.9% Sodium Chloride Injection, USP IV recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	EPINEPHrine Injection, USP, 1 mg/ (100 mcg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Ketamine HCl Injection, USP, 50 mg/ (50 mg/mL*) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Lidocaine HCl Injection, USP 1%, 50 mg/ (10 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	0.9% Buffered Lidocaine HCl (buffered recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022	CLASS II	Neostigmine Methylsulfate Injection, USP, 3 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

More recalls from Nephron Sterile Compounding Center

All 73

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Drug	CLASS II	Sodium Chloride Injection 9%, USP, Single-Dose IV recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 0.4 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

Other Labetalol recalls

All 16

Reported	Class	Recall	Company	Reason	Where
3 Jul 2024Drug	CLASS II	Labetalol Hydrochloride Injection, USP, 20 mg recalled by PfizerLabetalol Hydrochloride	Pfizer	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	labetalol HCl 20 mg/ Injection, (Concentration=5 mg/mL) fill Syringe recalled	SCA Pharmaceuticals	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Labetalol Hydrochloride Tablets, USP, 100 mg recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
8 Jun 2022Drug	CLASS II	Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
13 Jan 2021Drug	CLASS II	labetalol HCl 20 mg/, Injection for Intravenous Use (5mg/mL) recalled	SCA Pharmaceuticals	Sterility	Nationwide