Class II · Moderate risk
Labetalol Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Is Labetalol recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Labetalol (20 total). Check the affected lots below.
Most common reason: Sterility / contamination (10 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Labetalol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Labetalol recalls on record
none so far in 2026; 20 on record, newest first
Class II · Moderate risk
labetalol HCl 20 mg/4mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Labetalol Hydrochloride Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
labetalol HCl 20 mg/4 mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Labetalol HCl 5 mg/mL 20 mg/4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Labetalol 20 mg/4 mL
Lack of sterility assurance.
Class II · Moderate risk
Labetalol 20mg
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class III · Low risk
labetalol HCl injection 20 mg/4 mL
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Class II · Moderate risk
Labetalol Hydrochloride Injection
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Class II · Moderate risk
Labetalol HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Labetalol HCl in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Labetalol HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
labetalol HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Labetalol HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Labetalol Hydrochloride Injection
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Class II · Moderate risk
Labetalol Hydrochloride 5mg/Ml Injectable 100 Ml 80 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.