fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 36
Summary
The FDA issued a Class II for fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, by IntegraDose Compounding Services LLC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0548-2026
Action Date
2026-05-27
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot#: 20260310FEN-1, Exp. Date: 09/06/2026
Quantity Affected: 376 cassettes
Reason for Recall
Subpotent Drug
Distribution
Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-12
Company
Shoreview, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
IntegraDose Compounding Services LLC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IntegraDose Compounding Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IntegraDose Compounding Services LLC have FDA actions?
IntegraDose Compounding Services LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0548-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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