Labetalol recalls
The FDA has published 16 recalls involving Labetalol since 2012. The latest was reported on 3 Jul 2024. Most were for sterility. SCA Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 16 since 2012
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 1 latest 3 Jul 2024
Recalls per month, last 24 months click a bar for that month Severity split
0 0%15 94%1 6%
Why labetalol is recalled
Ongoing labetalol recalls 1 active
All labetalol recalls, newest first 16 total Reported Class Recall Company Reason Where 3 Jul 2024 Drug CLASS II Labetalol Hydrochloride Injection, USP, 20 mg recalled by Pfizer Labetalol Hydrochloride Pfizer Sterility Nationwide 3 Apr 2024 Drug CLASS II labetalol HCl 20 mg/ Injection, (Concentration=5 mg/mL) fill Syringe recalled SCA Pharmaceuticals Sterility Nationwide 27 Jul 2022 Drug CLASS II Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) syringe recalled Nephron Sterile Compounding Center Sterility Nationwide 15 Jun 2022 Drug CLASS II Labetalol Hydrochloride Tablets, USP, 100 mg recalled Mckesson Medical-Surgical Inc. Corporate Office Manufacturing (CGMP) Deviations Nationwide 8 Jun 2022 Drug CLASS II Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) recalled Nephron Sterile Compounding Center Sterility Nationwide 13 Jan 2021 Drug CLASS II labetalol HCl 20 mg/, Injection for Intravenous Use (5mg/mL) recalled SCA Pharmaceuticals Sterility Nationwide 9 Oct 2019 Drug CLASS II Labetalol HCl 5 mg/mL 20 mg/ (5 mg/mL) Fill in a Single Dose Syringe recalled KRS Global Biotechnology Sterility Nationwide 1 May 2019 Drug CLASS II Labetalol 20 mg/, 20 mg in syringe, Made recalled CMC Enterprise Pharmacy Sterility NC 20 Feb 2019 Drug CLASS II Labetalol 20mg, HCL, USP Injectable Solution, 20mg recalled Avella of Deer Valley Inc. Store 38 Packaging Defects 13 states 14 Mar 2018 Drug CLASS III labetalol HCl injection 20 mg/ (5mg/mL) syringe recalled SCA Pharmaceuticals Other GA, NE, PA 14 Mar 2018 Drug CLASS II Labetalol Hydrochloride Injection, USP, 100 mg recalled Hospira Inc. A Pfizer Foreign Material Nationwide 28 Feb 2018 Drug CLASS II Labetalol HCl in 0.9% Sodium Chloride in all strengths recalled Pharmedium Services Sterility Nationwide 28 Feb 2018 Drug CLASS II Labetalol HCl in all strengths, all doses, and all packaging recalled Pharmedium Services Sterility Nationwide 19 Oct 2016 Drug CLASS II labetalol HCl, 5 mg per mL, 20 mg per total Volume recalled Pharmedium Services Potency & Assay Nationwide 16 Jul 2014 Drug CLASS II Labetalol Hydrochloride Injection, USP, 100 mg recalled by Hospira Hospira Particulate Matter Nationwide 22 Aug 2012 Drug CLASS II Labetalol Hydrochloride 5mg/ML Injectable (2 Different Products) recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide
Should you stop taking Labetalol?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.