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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Aripiprazole Tablets Recalled for Superpotency

Agency Publication Date: September 12, 2025
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Summary

Ascend Laboratories, LLC is recalling 2,256 bottles of Aripiprazole Tablets (10 mg) because the medication is superpotent, meaning it contains more of the active ingredient than specified. This recall affects 30-count bottles of the prescription medication aripiprazole, which is used to treat certain mental/mood disorders. If you are taking this medication, you should contact your healthcare provider or pharmacist immediately to discuss your treatment and ensure you have safe medication.

Risk

Superpotent medication can lead to an accidental overdose, which may cause serious side effects or adverse health reactions depending on the patient's sensitivity to the drug's active ingredients.

What You Should Do

  1. Check your medication bottle for Aripiprazole Tablets, USP, 10 mg (30-count) with NDC 67877-432-03.
  2. Verify if your bottle belongs to lot number 24144162 with an expiration date of 09/2027.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Aripiprazole Tablets, USP (30-count bottle)by Ascend Laboratories, LLC
Variants: 10 mg, Tablet
Lot Numbers:
24144162 (Exp. 09/2027)
NDC:
67877-432-03

Manufactured by Alken Laboratories Ltd., INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97511
Status: Active
Manufacturer: Ascend Laboratories, LLC
Sold By: Pharmacies
Manufactured In: India
Units Affected: 2,256 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.