Labetalol HCl Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterility defect in an injectable product. Although no illnesses or injuries have been reported, lack of sterility assurance in injected medications represents a significant risk of serious infection.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling labetalol HCl 20 mg/4mL Injection (5 mg/mL, 4 mL syringe) due to lack of assurance of sterility. The affected product includes 2,458 syringes with NDC 70004-0700-28 distributed nationwide.
Two lot numbers are affected: Lot #1223047334 (Exp 12/23/23) and Lot #1223048170 (Exp 02/01/24).
Labetalol is an injectable medication used to treat high blood pressure. Lack of sterility assurance in injectable products poses a risk of infection if the product has been compromised during manufacturing or storage.
Patients and healthcare providers should verify medication lot numbers and contact SCA Pharmaceuticals or their healthcare provider if they have received product from the affected lots. Affected medication should not be used.
The recalled product
- Product
- labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Affected units
- 2,458
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1223047334 Exp 12/23/23
- 1223048170 Exp 02/01/24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by SCA Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 32 products in this recall →Related recalls
Same manufacturer · SCA Pharmaceuticals, LLC
See all →- HighPhenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
- HighInjectable midazolam HCl recalled due to sterility assurance failure
FDA (Drugs) · 2024-04-03
- HighFentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
FDA (Drugs) · 2024-04-03
- HighHydromorphone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighHYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
Same hazard · sterility defect
See all →- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereIMULDOSA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-08
- HighChloraPrep One-Step antiseptic solution sterility assurance recall
FDA (Drugs) · 2026-07-01
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- HighMedline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
FDA (Devices) · 2026-05-06