FDAClass IIJuly 1, 2020

Aripiprazole Tablets recall: Labeling Error

Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav…

Why was Aripiprazole Tablets recalled?

Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 1905003298 Exp. 01/31/2021

Product
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav…
Recalling firm
Alembic Pharmaceuticals Limited
Quantity
19,153 bottles
Distribution
Nationwide in the U.S.
Recall date
July 1, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls