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Heritage Pharmaceuticals Inc

Heritage Pharmaceuticals Inc Recalls

All product recalls associated with Heritage Pharmaceuticals Inc.

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Recall Summary

Total Recalls

158

Past Year

14

Class I (Serious)

23

Most Recent

Oct 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 1–20 of 158 recalls

Desipramine Tablets 10mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 75mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 25mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

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Class II

Moderate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 150mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 100mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 50mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

STA Liatest D-Di (Diagnostica Stago) – D-Dimer Level Underestimation (2025)

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

FDASep 12, 2025Nationwide• Diagnostica Stago, Inc.

STA-Fibrinogen 5 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Liquid Anti-Xa 8 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Liquid Anti-Xa 4 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA Satellite (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Owren Koller (Diagnostica Stago) – Clotting Time Inaccuracy (2025)

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

FDAMay 21, 2025IN, PR• Diagnostica Stago, Inc.

Jumbo Pumpkin Seeds (Organic Traditions) – Salmonella Risk (2025)

Product may be contaminated with Salmonella

FDAMay 7, 2025NJ, NY, VA• Advantage Health Matters Inc.

NxStage PureFlow-B Solution (NxStage) – Seal Failure Risk (2025)

Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.

FDAApr 28, 2025Nationwide• NxStage Medical Inc

NxStage Medical Inc: NxStage PureFlow-B Solution, Premixed Dialysate for Hemod...

The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.

FDAMay 14, 2024Nationwide• NxStage Medical Inc

Raiz de Tejocote Supplements (Backstage Center) - toxic ingredient (2024)

The "Alipotec King" Alipotec Raiz de Tejocote product was found to contain toxic yellow oleander instead of tejocote.

FDAFeb 23, 2024Nationwide• Backstage Center DBA CTC Seller

NxStage MDS Corporation: NxStage Cartridge Express with Speedswap, Catalog No. CAR...

Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.

FDAJan 29, 2024AZ, CA, CO +16 more• NxStage MDS Corporation

Diagnostica Stago, Inc.: STA Compact Automated Multi-Parametric Analyzer, Referenc...

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA Compact Max fully automatic clinical analyzer, Refere...

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA R Max fully automatic clinical instrument designed to...

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

FDAMar 22, 2023Nationwide• Diagnostica Stago, Inc.