May 2026 FDA Recall Drug by Integradose Compounding Services Llc
D-0548-2026 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Integradose Compounding Services Llc on May 12, 2026 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0548-2026

Reason for Recall
Subpotent Drug
Initiated
05-12-2026
Reported
05-27-2026
Quantity
376 cassettes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98991
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
IntegraDose Compounding Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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