Class II · Moderate risk
Risperidone 1mg/Ml 30ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Is Risperidone recalled?
Not under an active recall.
Risperidone was recalled 6 times in the past — all now closed. Most recent: Mar 15, 2021.
Most common reason: Impurity / degradation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Risperidone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Risperidone recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
RisperiDONE Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
RisperiDONE Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class III · Low risk
risperiDONE ORALLY DISINTEGRATING TABLETS
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Class III · Low risk
Risperidone Oral Solution
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Class II · Moderate risk
Risperdal CONSTA
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.