Reported Jul 1, 2020 · Terminated

Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited…

Alembic Pharmaceuticals Limited

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: Alembic Pharmaceuticals Limited · Near Baska · Tajpura, N/A · N/A

Is this the product you have?

  • Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only
  • Manufactured byAlembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat
  • India Manufactured for
    • Alembic Pharmaceuticals
    • Inc. 750 Route 202
    • Bridgewater
    • NJ 08807 USA
    • NDC 62332-097-30
Lot codes and dates
  • Lot1905003298 Exp. 01/31/2021
Amount recalled
19,153 bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.

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 Jan 19, 2022 · Data as of Sep 19, 5:54 PM UTC

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