FDAClass IIApril 9, 2025

Atorvastatin Calcium Tablets USP 40 mg recall: Failed Dissolution

Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by…

Why was Atorvastatin Calcium Tablets USP 40 mg recalled?

Failed dissolution specifications: lower than specifications

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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#: AVC24035, Exp 03/31/26

Product
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by…
Recalling firm
BIOCON PHARMA INC
Quantity
2184 bottles
Distribution
U.S.A. nationwide
Recall date
April 9, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls