Phenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.
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 risk-of-harm injectable product with sterility concerns. No illnesses, injuries, or hospitalizations are reported in the source, and the hazard remains theoretical, which limits the score to 3 per the rubric.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling Phenylephrine HCl 1000 mcg/10 mL injections distributed nationwide in 10 mL prefilled syringes (NDC 70004-0810-12). The recall was initiated due to lack of assurance of sterility.
Approximately 33,072 syringes were distributed, with an expanded recall of an additional 9,041 units. The affected lots span multiple batches with expiration dates from December 2023 through June 2024.
Healthcare facilities should check their inventory for affected lots and quarantine these units. Patients who have received this medication should contact their healthcare provider to discuss potential concerns related to the sterility assurance issue.
The recalled product
- Product
- PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- Hazard
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 (19)
- Lot #: 1223045536 Exp 12/06/23
- 1223045710 Exp 12/10/23
- 1223046574 Exp 01/12/24
- 1223047579 Exp 02/21/24
- 1223047764 Exp 03/06/24
- 1223048363 Exp 03/30/24
- 1223048364 Exp 03/30/24
- 1223048566 Exp 04/06/24
- 1223048573 Exp 04/07/24
- 1223048574 Exp 04/07/24
- 1223048643 Exp 04/11/24
- 1223048697 Exp 04/12/24
- 1223048742 Exp 04/13/24 Expanded lots#: 1223048065
- Exp 04/06/2024
- 1223048395
- 1223048397
- Exp 03/27/2024
- 1223049980
- Exp 06/05/2024
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 →- HighInjectable Phenylephrine Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03
- HighSuccinylcholine Chloride Injection Recalled for 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 · contamination risk
See all →- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
- SevereMedical Convenience Kits Recalled Over Lidocaine Injection Supplier Quality Issues
FDA (Devices) · 2026-08-05
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22