Reported Feb 15, 2023 · Terminated

Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin,…

Biocon Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BIOCON PHARMA INC · 485 HWY 1 (S) · ISELIN, NJ · 08830

Is this the product you have?

  • Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only
  • Manufactured forBiocon Pharma Inc., Iselin, NJ 08830-3009
  • Manufactured byBiocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11
Lot codes and dates
    • Lot #: BF21003163
    • BF21003246
    • BF21003161
    • Exp. Sep-2023
    • BF21004742
    • Exp. Dec-2023
    • BF22003359
    • Exp. Sep-2025
Amount recalled
3665 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 21, 2024 · Data as of Sep 19, 5:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.