Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Posaconazole Delayed-Release Tablets Recalled by BIOCON PHARMA INC Due to Failed Impurities/Degradation Specifications: High Out Of Specification degradation...

Date: January 31, 2023
Company: BIOCON PHARMA INC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BIOCON PHARMA INC directly.

Affected Products

Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.

Quantity: 3665 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About BIOCON PHARMA INC

BIOCON PHARMA INC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report