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Drug FDA Class II Ongoing Sub/super-potent

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.

IntegraDose Compounding Services LLC Published May 27, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact IntegraDose Compounding Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Subpotent Drug

Hazards

Subpotency · primary

Affected products (1)

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.

376 cassettes

Code info: Lot#: 20260310FEN-1, Exp. Date: 09/06/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    May 12, 2026
  2. Published
    May 27, 2026
Recall number
D-0548-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.