Fentanyl Injection (SCA Pharmaceuticals) – Subpotency Risk (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Brand
SCA Pharmaceuticals
Lot Codes / Batch Numbers
Lot #: 1220021578, Exp 12/2/2020, 1220021732, Exp 12/9/2020, 1220022385, Exp 12/29/2020, 1220022582, Exp 1/6/2021
Products Sold
Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021
SCA Pharmaceuticals is recalling Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., L due to Subpotency: Out-of-specification stability test result for low potency was obtained.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotency: Out-of-specification stability test result for low potency was obtained.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, LA, MO
Page updated: Jan 7, 2026