SCA Pharmaceuticals Fentanyl Products Recall: Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl products with potential lack of sterility assurance. Affected items include specific doses in 0.9% sodium chloride solution. Consumers should contact the manufacturer for details.
Recall notice
Lack Of Assurance Of Sterility.
Contact the company
What happened, in plain English
SCA Pharmaceuticals is recalling fentanyl products that may lack sterility assurance. This could pose a risk of infection if the medication is not properly sterile. The recall affects specific product doses sold with a particular lot number. Read more at govinfonow.com/recall/41124-sca-pharmaceuticals-fentanyl-products-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/41124-sca-pharmaceuticals-fentanyl-products-recall-lack-of-sterility-assurance · Updated October 7, 2026 · FDA enforcement record: FDA #D-0063-2018
Cite this page
“SCA Pharmaceuticals Fentanyl Products Recall: Lack of Sterility Assurance.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41124-sca-pharmaceuticals-fentanyl-products-recall-lack-of-sterility-assurance. Based on FDA recall #D-0063-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0063-2018%22&limit=1).
Why it’s dangerous
The products may not have been properly sterilized, which could lead to infections if the medication is used. This is a serious concern for medical treatments where sterility is critical.
Who’s affected
People who have received the recalled fentanyl products with the specific lot number (20170815) and NDC 70004-0264-64 are affected. Healthcare professionals using these products for medical purposes are at higher risk.
How to tell if you have this one
Check for the lot number 20170815 and NDC 70004-0264-64 on the product label. The products are single-dose CADD Cassettes for medical use only.
- Brand
SCA Pharmaceuticals- Category
Drug
All 10 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0059-2018 | SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29; Lot: 20170726@35 BUD: 10/24/2017 | 1248 syringes |
| D-0060-2018 | HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17; Lot: 20170808@52 BUD: 11/06/2017 | 128 syringes |
| D-0061-2018 | HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22; Lot: 20170816@65 BUD: 10/30/2017 | 60 bags |
| D-0062-2018 | fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40; Lot: 20170814@20 BUD: 11/12/2017 | 116 bags |
| D-0063-2018 | fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64; Lot: 20170815@26 BUD: 11/13/2017 | 20 bags inside rigid translucent plastic cases (CADD) |
| D-0064-2018 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205; Lots: a) 20170905@24 BUD: 12/04/2017 b) 20170901@25 BUD: 11/30/2017 | a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag |
| D-0065-2018 | oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44; Lot: 20170912@13 BUD: 10/22/2017 | 450 bags |
| D-0066-2018 | PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12; Lot: 20170920@53 BUD: 12/19/2017 | 1221 syringes |
| D-0067-2018 | Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30; Lot: 20170920@20 BUD: 11/09/2017 | 76 bags |
| D-0068-2018 | ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09; Lot: 20171004@4 BUD: 01/09/2018 | 487 syringes |
What to do — step by step
Check Product Label
Look for the lot number 20170815 and NDC 70004-0264-64 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the specific product being recalled?
The recalled products are fentanyl as citrate 2 mcg/mL, ropivacaine HCl 0.1%, and total fentanyl dose (200 mcg per 100 mL) in 0.9% sodium chloride, single-dose CADD cassette.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0063-2018 (October 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0063-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.