March 2025 FDA Recall Atorvastatin Calcium by Biocon Pharma Inc
D-0306-2025 - Failed dissolution specifications
This Class II drug recall was voluntarily initiated by Biocon Pharma Inc on March 17, 2025 for the product Atorvastatin Calcium. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0306-2025
Failed dissolution specifications: lower than specifications
03-17-2025
04-09-2025
2184 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
BIOCON PHARMA INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
Batch or Lot Expiration Information
Lot# : AVC24035, Exp 03/31/26
