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SigmaPharm Laboratories LLC

SigmaPharm Laboratories LLC Recalls

All product recalls associated with SigmaPharm Laboratories LLC.

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Recall Summary

Total Recalls

1000

Past Year

100

Class I (Serious)

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 801–820 of 2670 recalls

Sodium Phenylbutyrate Powder (SigmaPharm) – Impurity Specification Failure (2021)

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Class IIModerate

FDAAug 13, 2021Nationwide• SigmaPharm Laboratories LLC

GaviLyte-C (Lupin) – Osmolarity Specification (2021)

Failed Stability Specification; Out of specification for Osmolarity

Class IIModerate

FDAJul 29, 2021Nationwide• Novel Laboratories, Inc. d.b.a LUPIN

Pimento Cheese Sandwich (Modern Vending) – undeclared fish (2021)

Fish not declared as an allergen

Class II

1...39 404142 43...134

Page 41 of 134Next

Moderate

FDAJul 27, 2021KY• Modern Distributors, Inc. dba Modern Vending

Alinity ci-series Control Module (Abbott) – Software Performance Issue (2021)

Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.

FDAJul 26, 2021Nationwide• Abbott Laboratories

Tizanidine HCl Tablets 4mg (Dr. Reddy's) – Tablet Specification Failure (2021)

Failed Tablet/Capsule Specification: Some tablets are shaved

Class IIModerate

FDAJul 19, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Alinity s System (Abbott) – Liquid Waste Pressure Risk (2021)

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

FDAJul 12, 2021Nationwide• Abbott Laboratories, Inc

Tuscany (Thor Motor Coach) – RV Equipment Issue (2021)

Thor Motor Coach (TMC) is recalling certain 2019 Challenger, Palazzo, Tuscany, 2019-2020 Miramar, 2019-2021 Aria, Outlaw, and Venetian recreational vehicles equipped with Hehr 6400 series windows. The adhesive that bonds the vented portion of the window may fail.

NHTSAJul 8, 2021Nationwide• THOR MOTOR COACH

Aequalis Humeral Heads (Tornier) – Graphite Exposure Risk (2021)

Potential patient exposure to the graphite substrate.

FDAJun 25, 2021CA, CO, CT +12 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France

Alinity c ALT Reagent (Abbott Laboratories) – Sample Recovery Issue (2021)

There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results.

FDAJun 10, 2021Nationwide• Abbott Laboratories

Activated ALT Reagent (Abbott Laboratories) – Sample Recovery Risk (2021)

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

FDAJun 10, 2021Nationwide• Abbott Laboratories

Thor Motor Coach (TMC) is recalling certain 2018-2022 Axis 25.6 and 2018-2021 Vegas 25.6 motorhomes. The heat shield between the LP tank and chassis muffler was not installed.

NHTSAJun 10, 2021Nationwide• THOR MOTOR COACH

RayStation (RaySearch) - Incorrect Beam Positioning (2021)

Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

FDAJun 8, 2021TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Atorvastatin Calcium Tablets (Dr. Reddy's) - Impurity Detection (2021)

Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities

Class IIILow

FDAJun 4, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Aequalis Ascend Shoulder System (Tornier) - Incorrect Component Thickness (2021)

Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

FDAMay 28, 2021IL, TX• Tornier, Inc

Thor Tellaro (Thor Motor Coach) – Solar Panel Hazard (2021)

Fire/Burn Risk

Thor Motor Coach (TMC) is recalling certain 2022 Rize, Scope, Sequence, and Tellaro vehicles. The Flex-190 Solar Panel junction box may short.

NHTSAMay 26, 2021Nationwide• THOR MOTOR COACH

Chicken Street Taco Kit (Hy-Vee) – Undeclared Egg (2021)

Undeclared Allergen

Product contains chipotle crema as part of a taco kit which contains undeclared major food allergen egg

Class IHigh

FDAMay 24, 2021IL, IN, IA +6 more• Hy-Vee Stores Inc

Organic Dark Chocolate Blueberries (Torn Ranch) – Undeclared allergen (2021)

Undeclared Allergen

Recalling one lot code of Torn Ranch Organic Dark Chocolate Blueberries 18 oz. resealable bags due to a potential for an undeclared allergen (TREE NUTS- ALMONDS).

Class IHigh

FDAMay 18, 2021AK, ID, OR +1 more• Torn Ranch LLC.

NEFA CAL Standard (Randox) – Calibration Value Error (2021)

Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples

FDAMay 10, 2021Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Stay Informed

SigmaPharm Laboratories LLC Recalls

Recall Summary

Sodium Phenylbutyrate Powder (SigmaPharm) – Impurity Specification Failure (2021)

GaviLyte-C (Lupin) – Osmolarity Specification (2021)

Pimento Cheese Sandwich (Modern Vending) – undeclared fish (2021)

Alinity ci-series Control Module (Abbott) – Software Performance Issue (2021)

Tizanidine HCl Tablets 4mg (Dr. Reddy's) – Tablet Specification Failure (2021)

Alinity s System (Abbott) – Liquid Waste Pressure Risk (2021)

Tuscany (Thor Motor Coach) – RV Equipment Issue (2021)

Aequalis Humeral Heads (Tornier) – Graphite Exposure Risk (2021)

Alinity c ALT Reagent (Abbott Laboratories) – Sample Recovery Issue (2021)

Activated ALT Reagent (Abbott Laboratories) – Sample Recovery Risk (2021)

Activated ALT Reagent (Abbott Laboratories) – Sample Recovery Problem (2021)

Activated ALT Reagent (Abbott Laboratories) – Sample Recovery Concern (2021)

Thor Motor Coach Axis (Thor Motor Coach) – Heat Shield Problem (2021)

RayStation (RaySearch) - Incorrect Beam Positioning (2021)

Atorvastatin Calcium Tablets (Dr. Reddy's) - Impurity Detection (2021)

Aequalis Ascend Shoulder System (Tornier) - Incorrect Component Thickness (2021)

Thor Tellaro (Thor Motor Coach) – Solar Panel Hazard (2021)

Chicken Street Taco Kit (Hy-Vee) – Undeclared Egg (2021)

Organic Dark Chocolate Blueberries (Torn Ranch) – Undeclared allergen (2021)

NEFA CAL Standard (Randox) – Calibration Value Error (2021)