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Drug recall · FDA · Published November 20, 2020

SCA Pharmaceuticals recalls Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

SCA Pharmaceuticals recalls Fentanyl 250 mcg/5mL injections due to subpotency issues from stability testing. Affected lots expire by Dec 2020. Contact for details.

🇺🇸 FDA recall #D-0147-2021DrugSCA Pharmaceuticals ›
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Contact the company & request your remedy

Recalling firmSCA Pharmaceuticals755 Rainbow Rd Ste B, N/A · Windsor, CT 06095-1024
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

SCA Pharmaceuticals is recalling Fentanyl injections that may have lower potency than labeled. This could lead to ineffective pain relief if used as intended, though it doesn't pose an immediate safety risk. Read more at govinfonow.com/recall/36663-sca-pharmaceuticals-fentanyl-injection-recall-subpotency-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36663-sca-pharmaceuticals-fentanyl-injection-recall-subpotency-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0147-2021

Cite this page

“SCA Pharmaceuticals Fentanyl Injection Recall: Subpotency Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36663-sca-pharmaceuticals-fentanyl-injection-recall-subpotency-risk. Based on FDA recall #D-0147-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0147-2021%22&limit=1).

Why it’s dangerous

The injections failed stability tests showing lower potency than expected. This means the medication might not work as intended when administered, potentially requiring higher doses to achieve pain relief.

Who’s affected

Prescription users of Fentanyl injections for IV or IM use. Patients with specific medical conditions requiring precise dosing may be at slightly higher risk.

How to tell if you have this one

Check for lot numbers 1220021578 (exp 12/2/2020), 1220021732 (exp 12/9/2020), 1220022385 (exp 12/29/2020), or 1220022582 (exp 1/6/2021) on the packaging.

  • Brand
    SCA Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Number

    Look for lot numbers 1220021578, 1220021732, 1220022385, or 1220022582 on the injection vial.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The injections failed stability tests showing lower potency than expected, which could lead to ineffective pain relief.

What should I do if I have this product?

Check the lot number on the vial. If it matches the recalled lots, contact your healthcare provider for guidance.

Is there a risk of serious injury from this product?

No, the recall is for potential under-dosing, not an immediate safety hazard.

Take action

Contact SCA Pharmaceuticals

We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.

Subject: Recall D-0147-2021 — SCA Pharmaceuticals SCA Pharmaceuticals

Hello,

I own a SCA Pharmaceuticals that is covered by recall D-0147-2021 from SCA Pharmaceuticals.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0147-2021 (November 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0147-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA