Drug FDA Class II Ongoing Failed specifications

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

BIOCON PHARMA INC Published Apr 9, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact BIOCON PHARMA INC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed dissolution specifications: lower than specifications

Hazards

Failed Dissolution · primary

Affected products (1)

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

ATORVASTATIN CALCIUM · 2184 bottles

NDC: 70377-077, 70377-078, 70377-079, 70377-080, 70377-077-11, 70377-077-13, 70377-077-12, 70377-078-11, 70377-078-13, 70377-078-12, 70377-079-11, 70377-079-12, 70377-079-13, 70377-080-11, 70377-080-12, 70377-080-13

Code info: Lot#: AVC24035, Exp 03/31/26

Affected areas

Nationwide

Timeline

Initiated

Mar 17, 2025
Published

Apr 9, 2025

Recall number: D-0306-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.