BIOCON PHARMA INC Recalls

All product recalls associated with BIOCON PHARMA INC.

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Recall Summary

Total Recalls

12

Past Year

1

Class I (Serious)

1

Most Recent

Mar 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–12 of 12 recalls

Atorvastatin Tablets (Biocon) – Dissolution Failure (2025)

Failed dissolution specifications: lower than specifications

Class IIModerate

FDAMar 17, 2025Nationwide• BIOCON PHARMA INC

Atovaquone Oral Suspension (Bionpharma) – Bacterial Contamination (2024)

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

Class IHigh

FDASep 17, 2024Nationwide• Bionpharma Inc.

Nurtec ODT (Pfizer) – Packaging Safety Issue (2023)

This recall involves prescription drugs Nurtec ODT 75 mg orally disintegrating tablets sold in cartons containing one blister card of 8 tablets. The tablets are in a non-child resistant blister card packaged in a carton that includes the name of the product, dosage strength, expiration date. The dosage strength and expiration date are printed or stamped on the blister card. The recall includes the following: Product Description NDC Number Expiration Date Nurtec® ODT (rimegepant) 75mg 8-Unit Dose blister pack 72618-3000-2 All dates through 6/2026

CPSCMar 16, 2023Nationwide• Biohaven Pharmaceuticals Inc., of New Haven, Conn.

Posaconazole Tablets (Biocon Pharma) – High Impurities (2023)

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

Class IIModerate

FDAJan 31, 2023Nationwide• BIOCON PHARMA INC

Auryxia (Akebia) – dissolution failure (2021)

Failed Dissolution Specifications

Class IIILow

FDAJan 29, 2021Nationwide• Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Auryxia (Akebia Therapeutics) – manufacturing deviation (2020)

CGMP Deviations

Class IIModerate

FDADec 9, 2020Nationwide• Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Auryxia Tablets (Keryx Biopharmaceuticals) – Manufacturing Deviation (2020)

cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.

Class IIModerate

FDAJul 10, 2020Nationwide• Keryx Biopharmaceuticals, Inc.

Clobazam Oral Suspension (Bionpharma) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

Class IIModerate

FDAJul 16, 2019Nationwide• Bionpharma Inc.

Auryxia Tablets (Keryx) – Foreign Substance Risk (2017)

Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.

Class IIILow

FDADec 12, 2017Nationwide• Keryx Biopharmaceuticals, Inc.

Ranitidine Syrup (Bio-pharm) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

Class IIILow

FDADec 17, 2015Nationwide• Bio-pharm, Inc.

Thera-Gesic Pain Cream (BioComp) – subpotent ingredients (2015)

Subpotent Drug: menthol and methyl salicylate below specification

Class IIILow

FDAJul 6, 2015Nationwide• BioComp Pharma, Inc.

Children's Acetaminophen (Bio-pharm) – superpotent drug (2014)

Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.

Class IIModerate

FDAJul 16, 2014Nationwide• Bio-pharm, Inc.

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BIOCON PHARMA INC Recalls

Recall Summary

Atorvastatin Tablets (Biocon) – Dissolution Failure (2025)

Atovaquone Oral Suspension (Bionpharma) – Bacterial Contamination (2024)

Nurtec ODT (Pfizer) – Packaging Safety Issue (2023)

Posaconazole Tablets (Biocon Pharma) – High Impurities (2023)

Auryxia (Akebia) – dissolution failure (2021)

Auryxia (Akebia Therapeutics) – manufacturing deviation (2020)

Auryxia Tablets (Keryx Biopharmaceuticals) – Manufacturing Deviation (2020)

Clobazam Oral Suspension (Bionpharma) – Microbial Contamination (2019)

Auryxia Tablets (Keryx) – Foreign Substance Risk (2017)

Ranitidine Syrup (Bio-pharm) – Impurity Specification Failure (2015)

Thera-Gesic Pain Cream (BioComp) – subpotent ingredients (2015)

Children's Acetaminophen (Bio-pharm) – superpotent drug (2014)