Class II · Moderate risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications
Is Paliperidone recalled?
Not under an active recall.
Paliperidone was recalled 5 times in the past — all now closed. Most recent: Feb 28, 2022.
Most common reason: Dissolution failure (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Paliperidone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Paliperidone recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Paliperidone Extended Release Tablets 9 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk
Paliperidone Extended Release Tablets 3 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I · High risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
Class II · Moderate risk
Paliperidone Extended-release Tablets
Failed Dissolution Specifications; three month stability time point.
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