HIGH

Ascend Laboratories Recalls Aripiprazole Tablets Due to Potency Risk

Ascend Laboratories, LLC recalled 2,256 bottles of Aripiprazole Tablets on August 28, 2025. The recall followed reports that the drug may be superpotent, posing serious health risks. Consumers should stop using the product immediately and consult healthcare providers.

Hazard Information

Superpotent drug

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter

Product Details

The recalled product is Aripiprazole Tablets, USP, 10 mg, sold in 30-count bottles. The lot number is 24144162 and the expiration date is September 2027. The tablets were manufactured by Alken Laboratories Ltd., India, and distributed nationwide by Ascend Laboratories, LLC.

The Hazard

The recall stems from concerns that the Aripiprazole Tablets may be superpotent. This increased potency can lead to severe side effects and adverse reactions in patients.

Reported Incidents

There are no specific incident reports or injury counts mentioned. However, the potential for serious health risks from superpotent drugs categorizes this recall as high risk.

What to Do

Consumers and healthcare providers should stop using Aripiprazole Tablets immediately. Contact Ascend Laboratories, LLC for guidance or consult your healthcare provider.

Contact Information

For more information, reach Ascend Laboratories, LLC at their office in Parsippany, NJ. Visit the FDA's recall page for further details.

Key Facts

  • Recall date: August 28, 2025
  • NDC: 67877-432-03
  • Quantity recalled: 2,256 bottles
  • Superpotent drug risk
  • Distributed nationwide in the USA
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: 24144162
Exp. Date 09/2027
UPC Codes
67877-430
67877-431
67877-432
+13 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
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