Medications & Supplements/Prescription Drugs

Alembic Pharmaceuticals Limited: Aripiprazole Tablets Recalled Due to Label Mix-Up and Wrong Dosage

Agency Publication Date: June 24, 2020

Summary

Alembic Pharmaceuticals is recalling 19,153 bottles of Aripiprazole Tablets, USP (the generic name for Abilify). Bottles that are labeled as containing 30 count of 2 mg tablets actually contain 100 count of 5 mg tablets. This label mix-up means consumers may unknowingly take a dose that is more than double what their doctor prescribed, while also receiving more tablets than indicated on the bottle.

Risk

Patients taking these tablets may inadvertently ingest a 5 mg dose instead of the intended 2 mg dose, which can lead to adverse effects associated with accidental overdose of this medication. If you or someone you care for is taking this medication, it is critical to verify the tablet strength immediately to avoid taking an incorrect dosage.

What You Should Do

Immediately check your prescription bottle for Aripiprazole Tablets, USP, 2 mg with NDC 62332-097-30 and Lot number 1905003298 (Expiration 01/31/2021).
Verify the contents of your bottle; if you have this specific lot, the tablets inside may be 5 mg strength instead of the 2 mg strength listed on the label.
Contact your healthcare provider or pharmacist immediately for guidance on how to proceed and to obtain a correct replacement prescription.
Return any unused product from the affected lot to your pharmacy for a refund and to ensure the incorrect medication is properly handled.
Contact Alembic Pharmaceuticals for further instructions regarding this recall.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Aripiprazole Tablets, USP, 2 mg (30 Tablets per bottle)

Model:

NDC 62332-097-30

Lot Numbers:

1905003298 (Exp. 01/31/2021)

Date Ranges: Expiration 01/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85835

Status: Resolved

Manufacturer: Alembic Pharmaceuticals Limited

Sold By: pharmacies

Manufactured In: India

Units Affected: 19,153 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 · 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.

Summary

Risk

What You Should Do

Immediately check your prescription bottle for Aripiprazole Tablets, USP, 2 mg with NDC 62332-097-30 and Lot number 1905003298 (Expiration 01/31/2021).

Verify the contents of your bottle; if you have this specific lot, the tablets inside may be 5 mg strength instead of the 2 mg strength listed on the label.

Contact your healthcare provider or pharmacist immediately for guidance on how to proceed and to obtain a correct replacement prescription.

Return any unused product from the affected lot to your pharmacy for a refund and to ensure the incorrect medication is properly handled.

Contact Alembic Pharmaceuticals for further instructions regarding this recall.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.