Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

labetalol HCl injection 20 mg/4 mL (5mg/mL) Recalled by SCA Pharmaceuticals, LLC. Due to Labeling; Incorrect or Missing Lot number/Expiration Date; some...

Date: February 22, 2018
Company: SCA Pharmaceuticals, LLC.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SCA Pharmaceuticals, LLC. directly.

Affected Products

labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028

Quantity: 480 syringes

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: GA, NE, PA

Affected (3 states)Not affected

About SCA Pharmaceuticals, LLC.

SCA Pharmaceuticals, LLC. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report