fentaNYL 1,250 mcg Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling fentaNYL 1,250 mcg/25 mL injection syringes due to lack of sterility assurance. The nationwide recall affects 1,259 syringes; patients should contact their healthcare provider.
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 FDA Class II recall affects an injectable pharmaceutical product where sterility assurance is critical. Although no illnesses or injuries have been reported, the lack of sterility assurance represents a significant risk of serious infection. Per the rubric, this qualifies as a risk-of-harm product without reported injury.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling fentaNYL 1,250 mcg/25 mL injection supplied in 25 mL single-dose syringes. The recall affects approximately 1,259 syringes distributed nationwide. The affected lots are 1223048522 (expires 12/07/23), 1223049168 (expires 01/04/24), and 1223049552 (expires 01/19/24), identified by NDC 70004-0200-17.
The recall is due to lack of assurance of sterility. Sterility is critical for injectable medications to prevent serious infections and other complications in patients.
Patients who have received this medication should contact their healthcare provider to discuss whether they need medical evaluation or follow-up care. Healthcare facilities and distributors have been notified of the recall and should cease distribution immediately.
The recalled product
- Product
- fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Opioid
- Affected units
- 1,259
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 (6)
- Lot #: 1223048522
- Exp 12/07/23
- 1223049168
- Exp 01/04/24
- 1223049552
- Exp 01/19/24
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 · 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