Reported Oct 31, 2018 · Terminated

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle…

Teva Pharmaceuticals USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505

Is this the product you have?

  • Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only
  • Manufactured byActavis Laboratories FL, Inc., Fort Lauderdale, FL 33314
  • Distributed byActavis Pharma, Inc., Parsippany, NJ 07054
Lot codes and dates
    • Lot #: a) 1220221A
    • Exp 03/2019
    • 1269627A
    • Exp 09/2019
    • 1274295A
    • Exp 10/2019
    • b) 1220222A
    • Exp 03/2019
    • 1270501A
    • Exp 09/2019
    • 1274296A
    • Exp 10/2019
    • 1288766A
    • Exp 01/2020
Amount recalled
27,816 bottles

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

Why it was recalled

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 13, 2020 · Data as of Sep 19, 6:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.