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Ascend Laboratories, LLC

Ascend Laboratories, LLC Recalls

All product recalls associated with Ascend Laboratories, LLC.

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Recall Summary

Total Recalls

1000

Past Year

100

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 261–280 of 2670 recalls

Fosfomycin Tromethamine Granules (Ascend) – Impurity Specification (2024)

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Class IIModerate

FDAJan 16, 2024Nationwide• Ascend Laboratories, LLC

Perform Reversed Glenoid Press-Fit (Tornier) – Incorrect Device Package (2024)

The incorrect device is contained in the labeled package.

Low

FDAJan 3, 2024AZ, AR, CA +6 more• Tornier, Inc

Tizanidine Tablets (Dr. Reddy's) – Foreign Tablets (2024)

Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.

Class IIModerate

FDA

1...12 131415 16...134

Page 14 of 134Next

Jan 2, 2024

Nationwide

• Dr. Reddy's Laboratories, Inc.

Ibuprofen Famotidine Tablets (Ascend) – Foreign Tablet (2023)

Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

Class IIModerate

FDADec 29, 2023Nationwide• Ascend Laboratories, LLC

Wellsley Farms Mini Quiches (Fillo Factory) – foreign material (2023)

Possible foreign material (aluminum)

Class IIModerate

FDADec 28, 2023CT, FL, IN +4 more• The Fillo Factory Inc.

Battle Motors LET2 (Battle Motors) – steering linkage fault (2023)

Battle Motors, Inc. (Battle Motors) is recalling certain 2023-2024 Let2 trucks. The drag link connecting the steering gear to the roadside steering knuckle may become deformed or break.

High

NHTSADec 27, 2023Nationwide• BATTLE MOTORS

Aldi Choceur Chocolate Bars (Astor) - Undeclared Coconut (2023)

Undeclared Allergen

Undeclared coconut

Class IIModerate

FDADec 18, 2023FL, IN• Astor Chocolate Corp.

Tacrolimus Capsules (Dr. Reddy's) – Foreign Tablet Discovered (2023)

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

Class IIModerate

FDADec 15, 2023Nationwide• Dr. Reddy's Laboratories, Inc.

RX Series Copper Assay (Randox) – Carryover Testing (2023)

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

Moderate

FDANov 29, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Calibration Serum Level 3 (Randox) – CK Total Bias (2023)

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

Moderate

FDANov 20, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Calibration Serum Level 3 (Randox) – Alkaline Phosphatase Misassignment (2023)

Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

Moderate

FDANov 20, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Calibration Serum Level 3 (Randox) – Transcription Errors (2023)

There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.

Low

FDANov 13, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Thor Motor Coach Scope (Thor) – Solar Panel Frame (2023)

Thor Motor Coach (TMC) is recalling certain 2021-2024 Thor Rize and Scope motorhomes. The solar panel frame may fracture around the mounting bolts, allowing the panel to detach from the vehicle.

High

NHTSANov 10, 2023Nationwide• THOR MOTOR COACH

LET Gel (Right Value Drug Stores) – Product Mix-up (2023)

Product Mix-up: Incorrect Product Formulation

Class IIILow

FDANov 9, 2023Nationwide• Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop

SEROLOGY ToRCH lgM (Randox) – reactivity decrease (2023)

A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

Moderate

FDANov 6, 2023NY, WV• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

AFTERBURN Whey Protein Bar (Doctors Scienfic Organica) – foreign material (2023)

Foreign material including disposable hairnet, shrink wrap and parchment paper.

Class IIModerate

FDANov 3, 2023Nationwide• Doctors Scienfic Organica

Lubricating Eye Drops (Major) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lubricating Tears Eye Drops (Major) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Probiotic Tri-Blend (Abbott) – unapproved drug (2023)

Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

Class IIModerate

FDAOct 31, 2023AL, AZ, AR +38 more• Abbott Laboratories

Kawasaki Lawn Mower Engines – fire risk (2023)

Fire/Burn Risk

This recall involves Kawasaki engines used in riding lawn mowers sold under the Ariens brand name with mower models IKON, IKON Onyx, and Apex, and under the Gravely brand name with mower models ZT X, ZT XL, ZT HD, and ZT HD Stealth, and under the Husqvarna brand name with mower models TS142TXD, TS242TXD, TS242XD, Z248F, and Z254F, and under the John Deere brand name with mower models Z330M and Z330R, and under the RedMax brand name with mower model RZT48. The recalled engines are model year 2023 FR730V, FR691V, and FR651V. The recalled engine model and serial numbers are located on the engine fan housing. The following model and serial number ranges are included in this recall. Engine Model Number Specification Number FR651V GS28 FR691V GS19 ES29 FR730V FS15 Engine Serial Number Range A full list of serial numbers included in this recall are on the firm's website at www.kawasakienginesusa.com/product-recall.html recall notice RP230415.

High

CPSCOct 26, 2023Nationwide• Kawasaki Motors Manufacturing Corp. U.S.A., of Maryville, Missouri