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BIOCON PHARMA INC

BIOCON PHARMA INC Recalls

All product recalls associated with BIOCON PHARMA INC.

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Recall Summary

Total Recalls

1000

Past Year

620

Class I (Serious)

Most Recent

Dec 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 461–480 of 10937 recalls

Atorvastatin Tablets (Biocon) – Dissolution Failure (2025)

Failed dissolution specifications: lower than specifications

Class IIModerate

FDAMar 17, 2025Nationwide• BIOCON PHARMA INC

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Low

FDAMar 14, 2025Nationwide• Merit Medical Systems, Inc.

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Low

FDA

1...22 232425 26...547

Page 24 of 547Next

Mar 14, 2025

Nationwide

• Merit Medical Systems, Inc.

Celsior Storage Solution (Institut Georges Lopez) – contamination risk (2025)

The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

Moderate

FDAMar 13, 2025Nationwide• INSTITUT GEORGES LOPEZ 6 ROUTE DE SAINT BONNET ST LAURENT DE CHAMOUSSET France

Gerolsteiner Sparkling Water (Gerolsteiner) – Laceration Hazard (2025)

Laceration Risk

This recall involves Gerolsteiner 750ml sparkling water bottles from two specific lots. The water was sold in large 750ml glass bottles or in cases containing 15 bottles. There is a white, blue and red label on the front of the bottle with the name "Gerolsteiner". The lot number is located on the lower part of the label. Affected bottles have a lot number 11/28/2024 L or 11/27/2024 L.

Moderate

CPSCMar 13, 2025Nationwide• Gerolsteiner Brunnen GmbH & Co. KG, of Germany

NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

Moderate

FDAMar 10, 2025Nationwide• Medtronic Xomed, Inc.

Omni-Macs Dietary Supplement (Veridance) – Excessive Iodine (2025)

Levels of iodine exceeding label claim

Class IIModerate

FDAMar 10, 2025IN, MO• Veridance Pharmacal, LLC

Venue Go Models R2/R3 (GE Medical Systems) – Battery Fire Risk (2025)

Fire/Burn Risk

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

High

FDAMar 6, 2025Nationwide• GE Medical Systems, LLC

Phosphate Reagent Bottles (Taylor Water Technologies) – test kit risk (2025)

Fire/Burn Risk

This recall involves the replacement reagent #1 bottles sold with Taylor Phosphate Test Kits #K-1106 and also sold separately. The kits are used to test the level of phosphate in water for pools, spas and aquariums. The water testing kits are labeled with the brand name "Taylor," the kit name "Phosphate Test" and part number "K-1106." The bottle in the kit that contains sulfuric acid is labeled with the brand name "Taylor," product name "Phosphate Reagent #1," part number "R-0980" and "A Size: 22 mL (.75 oz)." The replacement reagent bottle that is sold separately has the same label. Phosphate Reagent #1 has a shelf-life of 24 months.

High

CPSCMar 6, 2025Nationwide• Taylor Water Technologies LLC, of Sparks, Maryland

Venue Fit Models R3/R4 (GE Medical Systems) – Battery Fire Risk (2025)

Fire/Burn Risk

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

High

FDAMar 6, 2025Nationwide• GE Medical Systems, LLC

InPen Smart Insulin Pen (Medtronic) – Assembly Error (2025)

Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

Moderate

FDAMar 4, 2025AL, AZ, AR +38 more• Medtronic MiniMed, Inc.

Stimulation RC Programmer (Medtronic) – Software Communication Fault (2025)

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

Moderate

FDAMar 4, 2025Nationwide• Medtronic Neuromodulation

Dinstuhl's Cashew Crunch (Dinstuhl's) – undeclared milk (2025)

Undeclared Allergen

Undeclared allergen (milk)

Class IIModerate

FDAMar 4, 2025IN, MS, MO• Dinstuhl's Fine Candy Company, Inc.

Dinstuhl's Peanut Brittle (Dinstuhl's) – undeclared milk (2025)

Undeclared Allergen

Undeclared allergen (milk)

Class IIModerate

FDAMar 4, 2025IN, MS, MO• Dinstuhl's Fine Candy Company, Inc.

Dinstuhl's Pecan Brittle (Dinstuhl's) – undeclared milk (2025)

Undeclared Allergen

Undeclared allergen (milk)

Class IIModerate

FDAMar 4, 2025IN, MS, MO• Dinstuhl's Fine Candy Company, Inc.

Comprehensive Shoulder Stem (Zimmer) – Surgical Insertion Problem (2025)

Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

Moderate

FDAMar 3, 2025Nationwide• ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Deerpark Industrial Estate Oranmore Ireland

CDI OneView Monitoring System (Terumo) – Display Value Issue (2025)

During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.

Low

FDAMar 3, 2025FL, IL, MI +3 more• Terumo Cardiovascular Systems Corporation