Biocon Pharma Posaconazole Delayed-Release Tablets Recall

Why it was recalled

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

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0268-2023
Classification: Class II
Status: Terminated
Recall initiated: Jan 31, 2023
FDA report date: Feb 15, 2023
Quantity: 3665 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: BIOCON PHARMA INC

Original FDA data

Every field from FDA enforcement report D-0268-2023, exactly as published.

Show all FDA fields

City: ISELIN
State: NJ
Status: Terminated
Country: United States
Event ID: 91577
Address: 485 HWY 1 (S)
Code information: Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
Postal code: 08830
Report date: Feb 15, 2023
Product type: Drugs
Recall number: D-0268-2023
Classification: Class II
Recalling firm: BIOCON PHARMA INC
Product quantity: 3665 bottles
Termination date: Jun 21, 2024
Reason for recall: Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: Nationwide in the USA
Recall initiation date: Jan 31, 2023
Initial firm notification: E-Mail
Center classification date: Feb 14, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0268-2023, published Feb 15, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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