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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals: Fentanyl Injection Recalled Due to Subpotency Concerns

Agency Publication Date: December 14, 2020
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Summary

SCA Pharmaceuticals is recalling 4,843 syringes of Fentanyl injection (250 mcg/ 5mL) because testing revealed the medication may be less potent than required. This recall affects various lots of the drug that were distributed to three hospitals in Missouri and Louisiana. Because this is a prescription medication used for pain management, patients who may have received this product should consult their healthcare provider or pharmacist.

Risk

The medication was found to be 'subpotent,' meaning it contains less of the active ingredient than specified. If the drug is not at full strength, patients may receive an inadequate dose of pain medication, leading to poorly controlled pain or other complications during medical procedures.

What You Should Do

  1. Check your medication records or contact your hospital pharmacy to see if you received Fentanyl, 250 mcg/ 5mL syringes from SCA Pharmaceuticals with any of the following lot numbers: 1220021578 (Exp 12/2/2020), 1220021732 (Exp 12/9/2020), 1220022385 (Exp 12/29/2020), or 1220022582 (Exp 1/6/2021).
  2. If you identify that you have been treated with or possess any of the affected lots, contact your healthcare provider or pharmacist immediately for guidance.
  3. Return any unused product to the pharmacy or place of purchase for a refund and contact SCA Pharmaceuticals for further instructions regarding the disposal or return of the syringes.
  4. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fentanyl, Injection for IV or IM use (250 mcg/ 5mL)
Model:
Recall #: D-0147-2021
Lot Numbers:
1220021578 (Exp 12/2/2020)
1220021732 (Exp 12/9/2020)
1220022385 (Exp 12/29/2020)
1220022582 (Exp 1/6/2021)
Date Ranges: Exp 12/2/2020, Exp 12/9/2020, Exp 12/29/2020, Exp 1/6/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86802
Status: Resolved
Manufacturer: SCA Pharmaceuticals
Sold By: hospitals
Manufactured In: United States
Units Affected: 4,843 syringes
Distributed To: Missouri, Louisiana

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.