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Qualitest Pharmaceuticals

Qualitest Pharmaceuticals Recalls

All product recalls associated with Qualitest Pharmaceuticals.

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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 3821–3840 of 4747 recalls

MethylPREDNISolone Tablets (Qualitest) – Subpotent Medication (2014)

Subpotent; 6 month stability time point

Class IIILow

FDASep 11, 2014Nationwide• Qualitest Pharmaceuticals

Ortho-Clinical Diagnostics: VITROS 5600 Integrated System, System Product Code 680241...

Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).

Class IIModerate

FDASep 8, 2014Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS 4600 Chemistry System (VITROS 5,1 FS System family...

1...190 191192193 194...238

Page 192 of 238Next

Class IIModerate

FDASep 8, 2014Nationwide• Ortho-Clinical Diagnostics

Fluocinonide Gel (Fougera) – Stability Specification Failure (2014)

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

Class IIModerate

FDAAug 28, 2014Nationwide• Fougera Pharmaceuticals Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL)...

Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been d

Class IIModerate

FDAAug 28, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Oxycodone Acetaminophen Tablets (Qualitest) – broken tablet risk (2014)

Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.

Class IIModerate

FDAAug 27, 2014Nationwide• Qualitest Pharmaceuticals

Warfarin Sodium 2 mg Tablets (Taro) – content uniformity issue (2014)

Failed Content Uniformity Specifications.

Class IIILow

FDAAug 25, 2014Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Ortho-Clinical Diagnostics: VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Pr...

Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.

Class IIModerate

FDAAug 20, 2014Nationwide• Ortho-Clinical Diagnostics

ChiroThin Dietary Supplement (ChiroNutraceutical) – unapproved ingredients (2014)

Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.

Class IIILow

FDAAug 20, 2014Nationwide• ChiroNutraceutical LLC

Siemens Healthcare Diagnostics: ADVIA Centaur Immunoassay System (including refurbished u...

The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full

Class IIModerate

FDAAug 19, 2014Nationwide• Siemens Healthcare Diagnostics

Siemens Healthcare Diagnostics, Inc.: Siemens CentraLink Data Management System, software versi...

Laceration Risk

Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. The issue may cause the software to stop executing commands, including uploading validated results to the LIS. The issue is related to an internal software timer that overflows after 24 days. Automated rules triggered by task schedulers or by actions in the CentraLink user interface may also be affected. As each customer configuration is unique, in addition to the delay in uploading of validated results, the specific consequences of discontinued command execution will vary.

Class IIModerate

FDAAug 19, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics: ADVIA Centaur XP Immunoassay System (including refurbishe...

Class IIModerate

FDAAug 19, 2014Nationwide• Siemens Healthcare Diagnostics

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The C...

Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.

Class IIModerate

FDAAug 18, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista¿ HbA1c

In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t

Class IIModerate

FDAAug 14, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Snowmobiles (Arctic Cat) – Fuel Leak Fire Risk (2014)

Fire/Burn Risk

This recall involves model year 2014 Arctic Cat XF 7000 and ZR 7000 and model year 2015 XF 7000 and ZR 7000 snowmobiles. They were sold in a variety of green, black, orange and white color combinations. All XF and ZR 2014 models are included in this recall. Recalled 2015 model vehicles have the last six digits of the vehicle identification number (VIN) in the following ranges: 100920 through 100993 for the XF 7000 models and 100792 through 100919 for the ZR 7000. The fourth and fifth digits of the VIN, "14" or "15," correspond to the model year. The VIN appears on a sticker attached to the chassis near the rider's right foot rest. The model name appears on the front sides of the snowmobile.

CPSCAug 14, 2014Nationwide• Arctic Cat Inc., of Thief River Falls, Minn.

Smoke Detectors (Fyrnetics) – Failure to Alert (2014)

Fire/Burn Risk

This recall involves thirty-three models of the 400 and 500 series Edwards (ESL)-branded and Interlogix smoke detectors hard-wired into a security system. Edwards and Interlogix smoke detectors are identical. The 2-wire or 4-wire detectors are round, white and measure 6 inches across by 2 inches high. The smoke detectors were made for professional installation and used primarily in commercial buildings, schools, hotels/motels, apartments, dormitories and homes as part of the fire alarm system. Recalled units have date codes 13084 through 14059 with the first two digits representing the year, for example: 13 for 2013 and 14 for 2014; and the last three digits representing the day of the year, for example: 084 is the 84th day of 2013, which is March 25, 2013. The initials ESL, the date code and one of the following model numbers are printed on a label on the back of the detector's cover and on the product's packaging. 400 series: 429AT, 429C, 429CAD, 429CRT, 429CST, 429CT, 429CTAD, 449AT, 449C, 449CRT, 449CSRH, 449CSRT, 449CST, 449CSTE, 449CT and 449CTE. 500 Series: 511C, 518C, 521B, 521BXT, 521B-10PKDMP, 521B-10PKG, 521BXT-10PKG, 521BXT-DMP-10PKG, 528B, 528CRXT, 541C, 541C-10PKG, 541CXT, 541CXT-10PK and 548C.

CPSCAug 13, 2014Nationwide• Fyrnetics Limited of Hong Kong, China

Siemens Healthcare Diagnostics: ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens...

The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.

Class IIModerate

FDAAug 13, 2014Nationwide• Siemens Healthcare Diagnostics

Siemens Healthcare Diagnostics: ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siem...

Class IIModerate

FDAAug 13, 2014Nationwide• Siemens Healthcare Diagnostics

Cubicin (Cubist) – Particulate Matter Contamination (2014)

Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.

Class IHigh

FDAAug 8, 2014Nationwide• Cubist Pharmaceuticals, Inc.

Children's Q-PAP Acetaminophen Suspension (Qualitest) – Superpotent Drug (2014)

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Class IIModerate

FDAAug 6, 2014Nationwide• Qualitest Pharmaceuticals