Aripiprazole tablets recalled nationwide due to excess active ingredient
Ascend Laboratories is voluntarily recalling Aripiprazole 10 mg tablets nationwide because the tablets contain excess active ingredient. No illnesses or injuries have been reported.
What this means for you
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—excess active ingredient in a psychiatric medication—represents a concrete risk of harm that has not yet manifested in reported adverse events. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring 3 (High).
Plain-English summary
Ascend Laboratories, LLC is voluntarily recalling Aripiprazole Tablets, USP, 10 mg distributed nationwide in the United States. The affected product is in 30-count bottles from lot number 24144162 with an expiration date of 09/2027. A total of 2,256 bottles have been distributed.
The tablets are being recalled because they contain excess active ingredient (superpotent). This means the tablets contain more aripiprazole than the labeled dose of 10 mg.
Patients currently taking this medication should contact their healthcare provider or pharmacist immediately. Do not stop taking the medication without medical guidance, as this is a prescription drug. Healthcare providers and pharmacists should contact Ascend Laboratories for information about managing patients who may have received affected bottles.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Antipsychotic
- Hazard
- excess-active-ingredient
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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