SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling fentanyl citrate syringes due to a lack of assurance of sterility and potential for leaking.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile injectable drug with a risk of contamination (lack of sterility assurance) and physical defect (leaking), which poses a significant risk of harm.
Plain-English summary
SCA Pharmaceuticals is recalling fentanyl as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL single-dose syringes. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.
The affected product is identified by NDC# 70004-0225-24, Lot 20170510@40, with a best-use date of 8/8/2017. The recall is classified as Class II by the FDA. The distribution pattern is listed as nationwide.
Healthcare providers and patients should stop using the affected syringes and contact SCA Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
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 (1)
- Lot: 20170510@40 BUD: 8/8/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by SCA Pharmaceuticals 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 30 products in this recall →Related recalls
Same manufacturer · SCA Pharmaceuticals
See all →- HighSCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
FDA (Drugs) · 2023-08-02
- ModerateFDA recalls Oxytocin product for low potency nationwide
FDA (Drugs) · 2023-05-03
- ModerateFentanyl Injection Syringes Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2023-03-08
- ModerateNorepinephrine Injection Recalled Nationwide for Manufacturing Quality Deviations
FDA (Drugs) · 2022-05-11
- ModerateDrug recall: fentanyl and bupivacaine injectable solution manufacturing deviations
FDA (Drugs) · 2022-05-11
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- SevereSCA Pharmaceuticals Recalls Fentanyl Injectable Bags Due to Sterility Concerns
FDA (Drugs) · 2017-06-07
- SevereSCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2017-08-02
- SevereSCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2017-06-07
- HighFentanyl Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- SevereSCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Seam Leaks
FDA (Drugs) · 2017-06-07
- SevereSCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
FDA (Drugs) · 2021-01-13