Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brands
- ARIPIPRAZOLE, Ascend Laboratories LLC, Alken Laboratories Ltd
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ARIPIPRAZOLE, Ascend Laboratories LLC, Alken Laboratories Ltd
- Product type
- Aripiprazole Tablets 10 mg
- Model numbers
- Lot #: 24144162, Exp. Date 09/2027
- UPC codes
- 67877-430, 67877-431, 67877-432, 67877-433, 67877-434, 67877-435, 67877-431-03, 67877-431-01 +8 more
- Sizes
- 30-count bottles
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 28, 2025
Reported by FDA DRUG
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
ARIPIPRAZOLE is an antipsychotic medication used to treat conditions like schizophrenia and bipolar disorder. The 10 mg tablet is a common dosage form.
Why This Is Dangerous
Superpotent drug increases risk of overdose or adverse reactions if administered at normal dosages. Precise potency differential is not detailed in the recall notice.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Consumers may experience overdose symptoms or unexpected reactions if exposed to the superpotent lot; immediate cessation is advised.
Practical Guidance
How to identify if yours is affected
- Check Lot number 24144162
- Check Expiration date 09/2027
- 30-count bottle label shows ARIPIPRAZOLE 10 mg
Where to find product info
NDC and lot numbers are on the product label and packaging.
What timeline to expect
Recall notification letters will guide refunds or replacements; processing typically weeks.
If the manufacturer is unresponsive
- Document all communications
- Contact FDA MedWatch if the company is unresponsive
- Consider legal counsel if harm occurs.
How to prevent similar issues
- Verify NDC and lot numbers before dispensing or using medications
- Source medications from reputable, licensed pharmacies
- Report any adverse events per FDA guidelines
Documentation advice
Keep the recall letter, receipts, and any medical records in case of audit or claim.
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Product Details
Aripiprazole Tablets, USP, 10 mg, 30-count bottles. Manufactured by Alken Laboratories Ltd., INDIA. Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC 67877-432-03. Quantity: 2,256 bottles. Lot #: 24144162. Expiration: 09/2027. Sold nationwide in the USA.
Reported Incidents
No specific injuries or incidents are documented in the recall notice. The status is ACTIVE with a HIGH hazard level.
Key Facts
- ARIPIPRAZOLE 10 mg tablets
- Manufactured in India by Alken Laboratories Ltd.
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Safety Guide
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