Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1341-2020·Announced 2020-07-01

Alembic Recalls Aripiprazole Tablets Due to Labeling Error

Alembic Pharmaceuticals is recalling aripiprazole tablets because bottles labeled as 2 mg contained 5 mg tablets. The error affects 19,153 bottles distributed nationwide.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a labeling error involving a dosage discrepancy. Per the rubric, minor labeling errors and low-risk contamination without reported serious injury fall under the Moderate severity category.

Plain-English summary

Alembic Pharmaceuticals Limited is recalling 19,153 bottles of Aripiprazole Tablets, USP, 2 mg, 30 count. The recall was initiated due to a labeling error where bottles labeled as containing 2 mg tablets actually contained aripiprazole 5 mg tablets, 100 count.

The affected product is identified by Lot 1905003298 with an expiration date of 01/31/2021. The product was distributed nationwide in the U.S. The agency has classified this recall as Class II, indicating a situation in which use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product: ARIPIPRAZOLE (ARIPIPRAZOLE)
Brand: ARIPIPRAZOLE
Manufacturer: Alembic Pharmaceuticals Limited
Category: Drug — Prescription Medication
Hazard: mis-labeling
dosage-error
Affected units: 19,153

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 (1)

Lot: 1905003298 Exp. 01/31/2021

UPCs (1)

0362332097302

Distribution

Distributed nationwide across the United States.

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