Class II · Moderate risk
Gemcitabine Injection
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Is Gemcitabine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Gemcitabine (8 total). Check the affected lots below.
Most common reason: Particulate / foreign matter (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gemcitabine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Gemcitabine recalls in 2026
1 initiated in 2026, 8 in total — newest first
Class II · Moderate risk
Gemcitabine
Lack of Assurance of Sterility
Class II · Moderate risk
Gemcitabine Injection 200mg/5.26ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Gemcitabine 1910 MG / 250 ML NS IVPB
Lack of Assurance of Sterility
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class II · Moderate risk
Gemcitabine For Injection USP
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
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