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Denison Pharmaceuticals, LLC

Denison Pharmaceuticals, LLC Recalls

All product recalls associated with Denison Pharmaceuticals, LLC.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

Most Recent

Jan 2026

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 4421–4440 of 25002 recalls

Pin-Away Pyrental Pamoate (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

Buprenorphine Sublingual Tablets (Sun Pharma) – CGMP Issues (2023)

CGMP Deviations

Class IIModerate

FDAMay 3, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Colic Calm (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

1...220 221222223 224...1251

Page 222 of 1251Next

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

Safe Tussin PM (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

Safe Tussin DM (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

Legacy SmartBase (Implant Direct) – FDA Clearance (2023)

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

Moderate

FDAMay 2, 2023Nationwide• Implant Direct Sybron Manufacturing LLC

Norepinephrine Dextrose (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal TPN Starter Bag 4% (Central Admixture) – sterility risk (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Gold Medal Bleached Flour (General Mills) – salmonella risk (2023)

Salmonella

Flour has the potential to be contaminated with Salmonella.

Class IHigh

FDAApr 28, 2023Nationwide• General Mills, Inc

MSA MSG Comp Solution (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia Solution Low Potassium (Central Admixture) – sterility risk (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia No Potassium (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

HyperLyte CR Injection (Central Admixture) – sterility concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Vasopressin Sodium Chloride Injection (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

EPINEPHrine Sodium Chloride Injection (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Diphenhydramine Sodium Chloride Injection (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Heparin Sodium Chloride (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Vancomycin Sodium Chloride (Central Admixture) – Sterility Issues (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Potassium Phosphate Sodium Chloride (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal TPN Starter High Calcium (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.