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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)

84

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 121–140 of 2670 recalls

Dabigatran Etexilate 150mg (Ascend) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Meritor Front Drive Steer Axle (Meritor) – Axle Hub Lubrication Issue (2024)

Meritor, Inc. (Meritor) is recalling certain 10-16K and 18-23K front steer drive axles, part numbers FSD 8-16K and FSD 18. An insufficient amount of lubricant in the front steer drive (FSD) axle hubs may result in damage to the wheel bearings.

NHTSADec 9, 2024Nationwide• MERITOR

Javygtor Tablets 100mg (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

1...5 678 9...134

Page 7 of 134Next

Low

FDANov 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Guaifenesin Dextromethorphan Syrup (Harvard Drug Group) – Specification Failure (2024)

Failed Impurity/Degradation Specifications

Class IIModerate

FDANov 7, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Bevacizumab Sterile Injection (Tailstorm Health) – Sterility Concern (2024)

Lack of Sterility Assurance

Class IIModerate

FDANov 6, 2024Nationwide• Tailstorm Health INC

OneMultivitaminic GAF-PLUS (Armonia) – Undeclared Drugs (2024)

Undeclared Allergen

Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame

Class IIModerate

FDANov 6, 2024CA, FL, GA +9 more• Armonia Natural Store LLC

El Gallo Jalapeño Queso Salsa (Las Delicias) – Milk Warning (2024)

Product does not include statement: Contains milk

Class IIModerate

FDANov 5, 2024TX• Las Delicias Distributors, LLC

Hydralazine HCl Tablets (Major Pharmaceuticals) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

FDANov 5, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Jarritos Coconut Water – Seal Compromise (2024)

The hermetic seal on the lid of the cans may be compromised

Class IIModerate

FDANov 4, 2024AL, AR, DE +26 more• Tipp Distributors, Inc. dba Novamex

IBU Tablets (Dr. Reddy's) – Failed Specifications (2024)

Failed Tablet/Capsule Specifications

FDAOct 29, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Morphine Sulfate Tablets 30mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Morphine Sulfate Tablets 15mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Karl Storz Irrigation Tubing (Karl Storz) – Labeling Error (2024)

Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

FDAOct 21, 2024Nationwide• Karl Storz Endoscopy

Karl Storz Aggressive Cutter (Karl Storz) – Sterility Barrier Breach (2024)

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

FDAOct 11, 2024Nationwide• Karl Storz Endoscopy

Cinacalcet Tablets 60mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 90mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 30mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Strawberry Field Juice (Youngstown Grape) – Pasteurization Issue (2024)

Incomplete pasteurization

Class IIModerate

FDAOct 3, 2024AL, AZ, CA +36 more• Youngstown Grape Distributors, Inc.

Carrot Digest Juice (Youngstown Grape) – Pasteurization Issue (2024)

Incomplete pasteurization

Class IIModerate

FDAOct 3, 2024AL, AZ, CA +36 more• Youngstown Grape Distributors, Inc.

Mexican Sweet Bread (EM Tortillas) – Undeclared Allergens (2024)

Undeclared Allergen

Undeclared allergens; wheat, soy, and eggs.

Class IIModerate

FDAOct 3, 2024CA• EM Tortillas, LLC