Class II · Moderate risk
IC-Green (indocyanine green for injection, USP)
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Indocyanine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Indocyanine (8 total). Check the affected lots below.
Most common reason: Sterility / contamination (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Indocyanine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Indocyanine recalls on record
none so far in 2026; 8 on record, newest first
Class III · Low risk
IC-Green (indocyanine green for injection, USP)
Product is being recalled due to low pH value.
Class II · Moderate risk
Indocyanine Green
Lack of Assurance of Sterility
Class II · Moderate risk
Fluorescein/Indocyanine
Lack of Assurance of Sterility
Class III · Low risk
IC-GREEN (indocyanine green for injection, USP)
Subpotent Drug: Low out-of-specification potency result of the drug product.
Class II · Moderate risk
Indocyanine Green 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
Indocyanine Green - Kit 15mg Injectable 1 Kit
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.
Class II · Moderate risk
Fluorescein/Indocyanine
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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