Class II · Moderate risk
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and…
Lack of Processing Controls.
Is Capecitabine recalled?
Not under an active recall.
Capecitabine was recalled 5 times in the past — all now closed. Most recent: Apr 3, 2018.
Most common reason: cGMP deviation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Capecitabine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Capecitabine recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Capecitabine tablets USP 500 mg
Failed Dissolution Specifications: low test results at the 18 month time-point
Class II · Moderate risk
Capecitabine Tablets
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Class II · Moderate risk
Capecitabine active pharmaceutical ingredient packaged in varying…
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.
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