Class II · Moderate risk
5-Fluorouracil 1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Is Fluorouracil recalled?
Not under an active recall.
Fluorouracil was recalled 23 times in the past — all now closed. Most recent: Dec 22, 2022.
Most common reason: Sterility / contamination (17 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluorouracil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Fluorouracil recalls on record
none so far in 2026; 23 on record, newest first
Class II · Moderate risk
Fluorouracil
Lack of Processing Control
Class I · High risk
Fluorouracil Injection
Presence of Particulate Matter; glass particulates
Class II · Moderate risk
Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML…
Lack of Assurance of Sterility
Class II · Moderate risk
Fluorouracil 560 MG / 11.2 ML IVP
Lack of Assurance of Sterility
Class II · Moderate risk
Fluororacil 0.05% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
5-Fluorouracil in Vanicream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class I · High risk
ADRUCIL (fluorouracil injection, USP)
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Class II · Moderate risk
Fluorouracil 4250mg / D5W 285mL
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 4600mg / D5W 292 mL
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 3200mg / D5W 264mL
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 1560mg / D5w 281ml
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 1200mg / D5W 274mL
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 4800mg / D5W 296mL
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag
Lack of Assurance of Sterility: Sterility of product is not assured.
Class I · High risk
Adrucil (fluorouracil injection, USP)
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Class II · Moderate risk
5-Fluorouracil active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
5-Fluorouracil 1% ophthal
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
5-Fluorouracil pf in methocel 1% opthal
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
FLUOROURACIL* PF 50 mg/mL INJECTABLE
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
Fluorouracil Topical Cream USP
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Class II · Moderate risk
Fluorouracil
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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