Reported Apr 26, 2023 · Ongoing

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA…

Ascend Laboratories, LLC

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: Ascend Laboratories, LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707

Is this the product you have?

  • Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged
  • in 500-count bottle Manufactured byAlkem Laboratories Ltd
  • INDIA Distributed byAscend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
Lot codes and dates
  • Lot #22143120, Exp
  • DateJune 2024
Amount recalled
135 bottles

Where it was sold

  • Nationwide

Why it was recalled

Out of specification (OOS) for Spectroscopic Identification test by IR.

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

Data as of Sep 19, 5:06 PM UTC

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