FDA recall, , Moderate risk
IntegraDose Compounding Services Fentanyl Citrate Injection
FentaNYL Citrate injection is subpotent.
Summary by Recall Canary from the FDA notice
What happened
IntegraDose Compounding Services LLC of Shoreview, Minnesota, recalled fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, because the drug is subpotent. The recall began May 12, 2026, and the product was distributed nationwide. The FDA added the recall to its Enforcement Report on May 21, 2026, and the recall was in the weekly enforcement report on May 27, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
fentaNYL Citrate, Sterile CADD for Injection
- NDC
- 71139-6030-1
- Lot code
- 20260310FEN-1
Recall details
- Company began the recall
- Sold in
- Nationwide
- Company
- IntegraDose Compounding Services LLCShoreview, Minnesota
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98991
- Recall number
- D-0548-2026
- Quantity recalled
- 376 cassettes
All recalls from IntegraDose Compounding Services LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
