Skip to content
Back to recalls
Drug FDA Class II Ongoing Sub/super-potent

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03

Ascend Laboratories, LLC Published Sep 24, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Ascend Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Superpotent drug

Hazards

Superpotency · primary

Affected products (1)

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03

ARIPIPRAZOLE · 2,256 bottles

NDC: 67877-430, 67877-431, 67877-432, 67877-433, 67877-434, 67877-435, 67877-431-03, 67877-431-01, 67877-431-05, 67877-431-33, 67877-431-38, 67877-431-32, 67877-432-03, 67877-432-01, 67877-432-05, 67877-432-33, 67877-432-38, 67877-432-32, 67877-433-03, 67877-433-01, 67877-433-05, 67877-433-33, 67877-433-38, 67877-433-32, 67877-434-03, 67877-434-01, 67877-434-05, 67877-434-33, 67877-434-38, 67877-435-03, 67877-435-01, 67877-435-05, 67877-435-33, 67877-435-38, 67877-430-03, 67877-430-01, 67877-430-05, 67877-430-33, 67877-430-38, 67877-430-32
Code info: Lot #: 24144162, Exp. Date 09/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 28, 2025
  2. Published
    Sep 24, 2025
Recall number
D-0645-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.