Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Feb 12, 2016 (11 years ago)

Paliperidone Extended-release Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications; three month stability time point.

Cause type: Dissolution failure

The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.

What was recalled

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

Affected NDC 0378-3978-93

Compare with the code on your package — it is the most precise check available.

Drug: Paliperidone

Recalling firm
Mylan Pharmaceuticals Inc.
NDC code
0378-3978-93
Origin
WV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0840-2016 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Paliperidone recalls

See all
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.

Terminated Packaging defect Teva Pharmaceuticals USA NDC 0591-3695-30 D-0097-2019
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.

Terminated Packaging defect Teva Pharmaceuticals USA NDC 0591-3693-30 D-0096-2019
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.

Terminated Dissolution failure Teva Pharmaceuticals D-0960-2017

Other recalls by Mylan Pharmaceuticals Inc.

All 2016 recalls
Class II · Moderate risk

Prasugrel Tablets

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Ongoing Dissolution failure Mylan Pharmaceuticals Inc NDC 0378-5186-93 D-0839-2026