Why it was recalled
Superpotent drug
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 24144162, Exp. Date 09/2027
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0645-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 28, 2025
- FDA report date
- Sep 24, 2025
- Quantity
- 2,256 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0645-2025, exactly as published.
Show all FDA fields
- City
- Bedminster
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97511
- Address
- 135 Us Highway 202 206 Ste 15
- Code information
- Lot #: 24144162, Exp. Date 09/2027
- Postal code
- 07921-2608
- Report date
- Sep 24, 2025
- Product type
- Drugs
- Recall number
- D-0645-2025
- Classification
- Class II
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 2,256 bottles
- Reason for recall
- Superpotent drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Aug 28, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 12, 2025