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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

303

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 901–920 of 4747 recalls

cobas e801 Analyzer (Roche) – Software Signal Impact (2022)

Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.

FDAJul 14, 2022Nationwide• Roche Diagnostics Operations, Inc.

Lorazepam Injection 2mg (Hikma) – Compound Degradation (2022)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Class IIModerate

FDAJul 11, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Tacrolimus Ointment (Glenmark) – Packaging Defect (2022)

Defective Container: Tube split from side seam

1...44 454647 48...238

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Class III

Low

FDAJul 11, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Lorazepam Injection 4mg (Hikma) – Impurity Detection (2022)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Class IIModerate

FDAJul 11, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Lorazepam Injection 2mg (Hikma) – Impurity Concerns (2022)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Class IIModerate

FDAJul 11, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Ativan Injection (Hikma) – Compound Instability (2022)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Class IIModerate

FDAJul 11, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Insulin Glargine (Mylan) – Missing Medication Label (2022)

Labeling: Missing label: Label missing from some prefilled pens.

Class IHigh

FDAJul 5, 2022Nationwide• Mylan Pharmaceuticals Inc

Echelon -14 Micro Catheter (Micro Therapeutics) – Packaging Water Damage (2022)

Outer carton packaging of microcatheters were exposed to wet substance during transport.

FDAJun 30, 2022Nationwide• Micro Therapeutics, Inc.

Lidocaine Cream (Mohnark) – child-resistant packaging (2022)

The recall involves Mohnark Pharmaceuticals Lidocaine 4% Topical Anesthetic Cream. The product was sold in a white tube with a flip-top closure. Mohnark Pharmaceuticals is printed under the blue and green logo on the right side of the product tube. The lot code is located at the bottom of the product tube. The affected lot codes are 01202201, 210201, 210301, 210503, 210505, 210601, 211002 and 210401. The UPC 860002324906 is located on bottom side panel of the packaging.

CPSCJun 30, 2022Nationwide• Mohnark Pharmaceuticals Inc., of Davie, Fla.

Echelon -14, 45 Tip Shape (Micro Therapeutics) – Packaging Water Damage (2022)

Outer carton packaging of microcatheters were exposed to wet substance during transport.

FDAJun 30, 2022Nationwide• Micro Therapeutics, Inc.

Testosterone Gel 1% (Teva) – Superpotent Drug Issue (2022)

Superpotent Drug: Out of specification assay result was obtained during stability testing.

Class IIModerate

FDAJun 29, 2022Nationwide• Teva Pharmaceuticals USA Inc

Telmisartan Hydrochlorothiazide Tablets (Glenmark) – Packaging Issue (2022)

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Class IIModerate

FDAJun 29, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Desmopressin Acetate Tablets (Glenmark) – Manufacturing Deviation (2022)

CGMP Deviations

Class IIModerate

FDAJun 29, 2022IN, TX• Glenmark Pharmaceuticals Inc., USA

Telmisartan Hydrochlorothiazide Tablets (Glenmark) – Packaging Issue (2022)

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Class IIModerate

FDAJun 29, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Aspirin Dipyridamole Capsules (Glenmark) – Capsule Breakage (2022)

Failed Tablet/Capsule Specification : Capsule breakage

Class IIILow

FDAJun 29, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

BIOPHEN UFH Control Plasma (Aniara Diagnostica) – Incorrect Product Labeling (2022)

Incorrect product labeling was included in the package.

FDAJun 28, 2022IL, IN, MI• Aniara Diagnostica LLC

Atellica CH Iron_2 (Siemens Healthcare) – Falsely Elevated Results (2022)

Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

FDAJun 28, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.