Recalls / Class II
Class IID-0645-2025
Product
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
- Brand name
- Aripiprazole
- Generic name
- Aripiprazole
- Active ingredient
- Aripiprazole
- Route
- Oral
- NDCs
- 67877-430, 67877-431, 67877-432, 67877-433, 67877-434, 67877-435
- FDA application
- ANDA207105
- Affected lot / code info
- Lot #: 24144162, Exp. Date 09/2027
Why it was recalled
Superpotent drug
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 135 Us Highway 202 206 Ste 15, N/A, Bedminster, New Jersey 07921-2608
Distribution
- Quantity
- 2,256 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-08-28
- FDA classified
- 2025-09-12
- Posted by FDA
- 2025-09-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0645-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.