Aripiprazole 10 mg tablets recalled after testing superpotent in one lot
Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a superpotent prescription medicine may deliver more than the intended dose and no injuries are reported.
Plain-English summary
Aripiprazole Tablets, USP, 10 mg, in 30-count bottles and available on prescription only, manufactured by Alken Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC of Parsippany, New Jersey, NDC 67877-432-03, are being recalled. The affected product is lot 24144162 with an expiry of 09/2027, and the recall covers 2,256 bottles distributed nationwide.
The recall was issued because the product is superpotent. The FDA classified the action as Class II.
Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Central Nervous System
- Affected units
- 2,256
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 24144162
- Exp. Date 09/2027
Distribution
Distributed nationwide across the United States.
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