Fentanyl Citrate Sterile Injection Recalled for Subpotent Drug Content
IntegraDose Compounding Services LLC is recalling fentanyl citrate sterile injection (2,500 mcg/50mL) distributed nationwide due to subpotent drug content. The voluntary recall affects 376 cassettes with lot number 20260310FEN-1, expiration date 09/06/2026.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source specifies an FDA Class II classification. The source explicitly states no illnesses or injuries have been reported, and the hazard (subpotency) is a deficiency in active ingredient rather than a high-risk pathogen or acute safety threat. Per the rubric, this qualifies as Moderate.
Plain-English summary
IntegraDose Compounding Services LLC is voluntarily recalling fentanyl citrate sterile injection for CADD infusion devices. The affected product is fentanyl citrate, sterile, 2,500 mcg/50mL in sterile water, distributed nationwide. The lot number is 20260310FEN-1 with an expiration date of 09/06/2026. A total of 376 cassettes have been recalled.
The recall was initiated due to subpotent drug content. This means the product contains less active ingredient than specified, which could result in inadequate pain relief for patients who depend on consistent dosing. The recall is classified as a Class II recall by the FDA.
Patients and healthcare providers who have received this product should contact IntegraDose Compounding Services LLC at their Shoreview, Minnesota facility (3650 Victoria St N, Suite 900) or their healthcare provider for guidance. Do not use cassettes from the affected lot.
The recalled product
- Product
- fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
- Manufacturer
- IntegraDose Compounding Services LLC
- Category
- Drug — Injectable / Compounded
- Affected units
- 376
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 (2)
- Lot#: 20260310FEN-1
- Exp. Date: 09/06/2026
Distribution
Distributed nationwide across the United States.
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