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Class II: temporary or reversible health riskOngoing

IntegraDose Compounding Services fentaNYL Citrate Recall

fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, Integra…

IntegraDose Compounding Services LLC · Shoreview, MN

Risk level
Class II
Reported by FDA
May 27, 2026
Recall ID
D-0548-2026
Check your lot numberHow we source this data

Summary

IntegraDose Compounding Services recalled fentaNYL Citrate starting May 12, 2026. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0548-2026 on May 27, 2026. Reason: Subpotent Drug. Status: Ongoing.

Why it was recalled

Subpotent 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 numbers, UPCs & expiration codes

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

Where it was sold

Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0548-2026
Classification
Class II
Status
Ongoing
Recall initiated
May 12, 2026
FDA report date
May 27, 2026
Quantity
376 cassettes
Recall type
Voluntary: Firm initiated
Recalling firm
IntegraDose Compounding Services LLC

Original FDA data

Every field from FDA enforcement report D-0548-2026, exactly as published.

Show all FDA fields
City
Shoreview
State
MN
Status
Ongoing
Country
United States
Event ID
98991
Address
3650 Victoria St N Ste 900
Code information
Lot#: 20260310FEN-1, Exp. Date: 09/06/2026
Postal code
55126-2906
Report date
May 27, 2026
Product type
Drugs
Recall number
D-0548-2026
Classification
Class II
Recalling firm
IntegraDose Compounding Services LLC
Product quantity
376 cassettes
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide.
Recall initiation date
May 12, 2026
Center classification date
May 21, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0548-2026, published May 27, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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