All Recalls

Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.

May 28, 2025 Dairy & Eggs View Details →

Newly Weds B60960-BREAD CRUMBS X1-NET WT 6 LBS

Newly Weds Foods

🍎 Food Class I - Dangerous

potential Listeria Monocytogenes Contamination

Jul 15, 2025 Bakery & Bread View Details →

Newly Weds A93060 BREADER X1- NEW WT 40 LBS.

Newly Weds Foods

🍎 Food Class I - Dangerous

potential Listeria Monocytogenes Contamination

Jul 15, 2025 Bakery & Bread View Details →

Sheehan Brothers Vending Chili Cheese Coney, 4.3 oz (120g), in a red and white paper boat and individually wrapped in plastic, UPC: 100000222027

SHEEHAN BROTHERS VENDING

🍎 Food Class I - Dangerous

Undeclared sesame

Jul 8, 2025 Dairy & Eggs View Details →

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.

Lupin Pharmaceuticals

💊 Drugs Class I - Dangerous

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Jul 2, 2025 Prescription Drugs Nationwide View Details →

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

FDC Limited

💊 Drugs Class I - Dangerous

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Jul 5, 2025 Prescription Drugs Nationwide View Details →

Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.

Nostrum Laboratories

💊 Drugs Class I - Dangerous

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Jul 11, 2025 Prescription Drugs Nationwide View Details →

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02

Pfizer

💊 Drugs Class I - Dangerous

CGMP Deviations; particulates identified during visual inspection

Jul 10, 2025 Prescription Drugs Nationwide View Details →

Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

Hikma Pharmaceuticals USA

💊 Drugs Class I - Dangerous

Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

Jul 22, 2025 Prescription Drugs Nationwide View Details →

Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04

Pfizer

💊 Drugs Class I - Dangerous

CGMP Deviations; particulates identified during visual inspection

Jul 10, 2025 Prescription Drugs Nationwide View Details →

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04

Strides Pharma

💊 Drugs Class I - Dangerous

Failed Dissolution Specifications.

Jul 9, 2025 Prescription Drugs Nationwide View Details →

Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L. 23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L. 25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 31. AIC w/Impella Connect for ECP; Product Code: 1000432.

Abiomed

🏥 Medical Devices Class I - Dangerous

A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

Jun 23, 2025 Infusion Pumps Nationwide View Details →

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.

Jun 26, 2025 Other Medical Devices Nationwide View Details →

SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

Draeger

🏥 Medical Devices Class I - Dangerous

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Jun 16, 2025 Other Medical Devices Nationwide View Details →

Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);

Philips North America

🏥 Medical Devices Class I - Dangerous

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

Jun 30, 2025 Other Medical Devices Nationwide View Details →