Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,116 results
Pharmaceutical
FDA Drugs
FDA DrugsRosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
AvKARE
FDA DrugsClass II
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Out of specification for dissolution.
Jan 14, 2026AvKARE
PharmaceuticalFDA Drugs
FDA DrugsDexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Imprimis NJOF, LLC
FDA DrugsClass II
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Presence of particulate matter - Glass like particles.
Jan 14, 2026Imprimis NJOF, LLC
Medical DeviceFDA Devices
FDA DevicesThe Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Roche Diagnostics Operations, Inc.
FDA DevicesClass II
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Jan 14, 2026Roche Diagnostics Operations, Inc.
Food & BeverageFDA Food
FDA FoodSam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
Ambriola Co., Inc., The
FDA FoodClass I
Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
Product tested positive for Listeria Monocytogenes.
Jan 14, 2026Ambriola Co., Inc., The
Medical DeviceFDA Devices
FDA DevicesBD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.
CareFusion 303, Inc.
FDA DevicesClass II
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Jan 14, 2026CareFusion 303, Inc.
Medical DeviceFDA Devices
FDA DevicesThe Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa
FDA DevicesClass II
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Customer complaints of Pressio monitor rebooting.
Jan 14, 2026Sophysa
PharmaceuticalFDA Drugs
FDA DrugsDexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Imprimis NJOF, LLC
FDA DrugsClass II
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Presence of particulate matter - Glass like particles.
Jan 14, 2026Imprimis NJOF, LLC
Food & BeverageFDA Food
FDA FoodTita Crackers Rovira, 3 (1/2 oz (15g) Foil Fresh Packets Net Wt.8 oz (226.8 g) boxes, 6/8oz boxes per case. UPC 072981005121 Tita Crackers Rovira, Net Wt. 24 oz (680 g) boxes, 6/24 oz boxes per case. UPC 072981005343 Tita Crackers Rovira, Net Wt 24 oz (680 g) cans, 6/24 oz boxes per case.
Rovira Biscuit Corporation
FDA FoodClass II
Tita Crackers Rovira, 3 (1/2 oz (15g) Foil Fresh Packets Net Wt.8 oz (226.8 g) boxes, 6/8oz boxes per case. UPC 072981005121 Tita Crackers Rovira, Net Wt. 24 oz (680 g) boxes, 6/24 oz boxes per case. UPC 072981005343 Tita Crackers Rovira, Net Wt 24 oz (680 g) cans, 6/24 oz boxes per case.
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Jan 14, 2026Rovira Biscuit Corporation
Medical DeviceFDA Devices
FDA DevicesKii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Applied Medical Resources Corp
FDA DevicesClass II
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Jan 14, 2026Applied Medical Resources Corp
PharmaceuticalFDA Drugs
FDA DrugsOxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
SpecGx, LLC
FDA DrugsClass II
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Jan 14, 2026SpecGx, LLC
Medical DeviceFDA Devices
FDA DevicesArial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Securitas Healthcare LLC
FDA DevicesClass II
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Jan 14, 2026Securitas Healthcare LLC
Food & BeverageFDA Food
FDA FoodEggs Potatoes Cheese Tacos, Evergreen Refreshments brand, Ready to Eat, Refrigerated. Net wt. 6.3 oz. UPC 100040103898, EG03698v01. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Fresh & Ready Foods LLC
FDA FoodClass II
Eggs Potatoes Cheese Tacos, Evergreen Refreshments brand, Ready to Eat, Refrigerated. Net wt. 6.3 oz. UPC 100040103898, EG03698v01. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Foreign material.
Jan 14, 2026Fresh & Ready Foods LLC
Food & BeverageFDA Food
FDA FoodSapori Amaretti Almonds 175 g Cookies
D. Coluccio & Sons Inc.
FDA FoodClass II
Sapori Amaretti Almonds 175 g Cookies
Contains elevated levels of hydrocyanic acid
Jan 14, 2026D. Coluccio & Sons Inc.
Food & BeverageFDA Food
FDA FoodSpicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Fresh & Ready Foods LLC
FDA FoodClass II
Spicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Foreign material.
Jan 14, 2026Fresh & Ready Foods LLC
Food & BeverageFDA Food
FDA FoodItalian Parsley packaged in 24lb boxes, 40 bunches per box in plastic.
MAYEJ COMERCIALIZADORA S. de R.L. de C.V.
FDA FoodClass II
Italian Parsley packaged in 24lb boxes, 40 bunches per box in plastic.
pathogen Cyclospora cayetanensis
Jan 14, 2026MAYEJ COMERCIALIZADORA S. de R.L. de C.V.
Food & BeverageFDA Food
FDA FoodBaraka French Style Puff Pastry 1lb and 1.5lbs sizes, UPCs 8 22514 28540 3 and 8 22514 28550 2, both sizes 12 retail units per wholesale case
ZIYAD BROTHERS IMPORTING
FDA FoodClass II
Baraka French Style Puff Pastry 1lb and 1.5lbs sizes, UPCs 8 22514 28540 3 and 8 22514 28550 2, both sizes 12 retail units per wholesale case
May contain partially hydrogenated oils
Jan 14, 2026ZIYAD BROTHERS IMPORTING
Food & Beverage
RappelConso
RappelConsoauchan - auchan feuilletés st jacques 400g
auchan
RappelConsovolontaire (san...
auchan - auchan feuilletés st jacques 400g
présence possible d'un corps étranger (plastique)
Jan 14, 2026auchan
Food & BeverageFDA Food
FDA FoodPinna Grated Pecorino Romano 2/10, 10-pound plastic bags (units)
Ambriola Co., Inc., The
FDA FoodClass I
Pinna Grated Pecorino Romano 2/10, 10-pound plastic bags (units)
Product tested positive for Listeria Monocytogenes.
Jan 14, 2026Ambriola Co., Inc., The
Food & BeverageFDA Food
FDA FoodEverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)
GBC Food Services, LLC
FDA FoodClass I
EverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)
Potential presence of Listeria monocytogenes.
Jan 14, 2026GBC Food Services, LLC
Food & BeverageRappelConso
RappelConsomy huong (sarl ly) - samoussas au poulet halal surgeles
my huong (sarl ly)
RappelConsovolontaire (san...
my huong (sarl ly) - samoussas au poulet halal surgeles
présence de salmonelle
Jan 14, 2026my huong (sarl ly)
Medical DeviceFDA Devices
FDA DevicesPhilips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
FDA DevicesClass II
Philips Incisive CT
Potential for incomplete scan due to unstable connection inside of floating sensor.
Jan 14, 2026Philips Healthcare (Suzhou) Co., Ltd.
Medical DeviceFDA Devices
FDA DevicesImpella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Abiomed, Inc.
FDA DevicesClass II
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
Jan 14, 2026Abiomed, Inc.
Food & BeverageFDA Food
FDA FoodBaraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case
ZIYAD BROTHERS IMPORTING
FDA FoodClass II
Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case
May contain partially hydrogenated oils
Jan 14, 2026ZIYAD BROTHERS IMPORTING
Medical DeviceFDA Devices
FDA DevicesPhilips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Philips North America Llc
FDA DevicesClass II
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Jan 14, 2026Philips North America Llc