Labetalol HCl Injection (SCA) – Incorrect Labeling (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
SCA Pharmaceuticals, LLC.
Lot Codes / Batch Numbers
lot 1217000213, exp 03/27/2019
Products Sold
lot 1217000213, exp 03/27/2019
SCA Pharmaceuticals, LLC. is recalling labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, due to Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, NE, PA
Page updated: Jan 7, 2026