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Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. Recalls

All product recalls associated with Roche Diagnostics Operations, Inc..

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Recall Summary

Total Recalls

1000

Past Year

Class I (Serious)

Most Recent

Nov 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 221–240 of 2399 recalls

Tina-quant D-Dimer Test (Roche) – Result Elevation Issue (2023)

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

FDAOct 3, 2023Nationwide• Roche Diagnostics Operations, Inc.

Smooth Almond Butter (Maisie Jane's) – High aflatoxin (2023)

High levels of aflatoxin

Class IIModerate

FDAOct 2, 2023Nationwide• Maisie Jane's California Sunshine Products Inc.

Fentanyl/Bupivacaine Solution (CAPS) – sterility concern (2023)

Lack of assurance of sterility:

Class IIModerate

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Page 12 of 120Next

FDA

Sep 21, 2023

Nationwide

• Central Admixture Pharmacy Services Inc

Phenylephrine 400 mcg/10 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl Sodium Chloride (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl 500 mcg/50 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl 100 mcg/2 mL (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl 10 mcg/1 mL Sodium Chloride (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Succinylcholine 200 mg/10 mL (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl 300 mcg/30 mL Dextrose (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl Sodium Chloride (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Phenylephrine Sodium Chloride (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl Syringe (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Lidocaine Syringe (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Hydromorphone Sodium Chloride (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Ephedrine Sodium Chloride (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Rocuronium Syringe (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl Sodium Chloride (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Hydromorphone Dextrose (Central Admixture) – Sterility Concern (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc

Fentanyl 5000 mcg/100 mL (Central Admixture) – Sterility Risk (2023)

Lack of assurance of sterility:

Class IIModerate

FDASep 21, 2023Nationwide• Central Admixture Pharmacy Services Inc