Aripiprazole Tablets recall
FDA recall D-0645-2025 · initiated Aug 28, 2025
Ascend Laboratories, LLC recalled Aripiprazole Tablets in Aug 2025 — an FDA Class II recall (D-0645-2025) because Superpotent drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Superpotent drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,256 bottles
Details
- 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
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Aug 28, 2025
- FDA report date
- Sep 24, 2025
Frequently asked
- Was Aripiprazole Tablets recalled?
- Ascend Laboratories, LLC recalled Aripiprazole Tablets in Aug 2025 — an FDA Class II recall (D-0645-2025) because Superpotent drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Aripiprazole Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0645-2025 was: Superpotent drug
- Is a recalled Aripiprazole Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Aripiprazole Tablets are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot #: 24144162, Exp. Date 09/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0645-2025.