fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII recall
FDA recall D-0225-2025 · initiated Jan 31, 2025
Fagron Compounding Services recalled fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII in Jan 2025 — an FDA Class II recall (D-0225-2025) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1330 bags
Details
- Product
- fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
- Recalling company
- Fagron Compounding Services
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed in PA
- Initiated
- Jan 31, 2025
- FDA report date
- Feb 26, 2025
Frequently asked
- Was fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII recalled?
- Fagron Compounding Services recalled fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII in Jan 2025 — an FDA Class II recall (D-0225-2025) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII recalled?
- Per the FDA enforcement record, the reason for recall D-0225-2025 was: Lack of Assurance of Sterility
- Is a recalled fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII are affected?
- Distributed: Distributed in PA. The recall covers these lots — Lot # C274-000040409, Exp 03/22/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0225-2025.