CLASS III Drug recall · Reported 14 Mar 2018 · FDA Enforcement Report

labetalol HCl injection 20 mg/ (5mg/mL) syringe recalled

SCA Pharmaceuticals is recalling labetalol HCl injection 20 mg/ (5mg/mL) syringe, distributed in Georgia, Nebraska, Pennsylvania. The recall was initiated on 22 Feb 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codeslot 1217000213, exp 03/27/2019

Quantity recalled480 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-0603-2018
FDA event ID: 79265
Recalling firm: SCA Pharmaceuticals, Windsor, CT
Classification: Class III
Status: Terminated
Recall initiated: 22 Feb 2018
FDA classified: 19 Mar 2018
Reported: 14 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Injectable & IV Drugs

Timeline

22 Feb 2018	Recall initiated by company
14 Mar 2018	Published in enforcement report	+20 days
19 Mar 2018	Classified by FDA	+5 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

GA, NE & PA

Georgia Nebraska Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

lot 1217000213, exp 03/27/2019

Where was it sold?

GA, NE & PA

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

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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
27 Jul 2022Drug	CLASS II	Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) syringe recalled	Nephron Sterile Compounding Center	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