FDA Recall
OngoingHistorical recordClass II
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
by Westminster Pharmaceuticals LLC
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Published
- August 20, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
OngoingHistorical recordClass II
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
by Ascend Laboratories, LLC
- Reason
- Failed Dissolution Specifications: low dissolution results
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 26, 2026Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- Sysco Classic Tuna Salad, Reorder #6724249, net wt. 5lb. Foo…
- Reason
- Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
- Published
- August 20, 2025
- Distribution
- Distributed in AR, CO, FL, GA, IA, IL, I…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 26, 2026Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- Sysco Imperial Deluxe Tuna Salad, Reorder #6526826, net wt.…
- Reason
- Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
- Published
- August 20, 2025
- Distribution
- Distributed in AR, CO, FL, GA, IA, IL, I…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 26, 2026Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- Reser's Tuna Salad, net wt. 5lb. Foodservice item. Product i…
- Reason
- Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
- Published
- August 20, 2025
- Distribution
- Distributed in AR, CO, FL, GA, IA, IL, I…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 21, 2026Historical recordClass II
Jayone Foods, Inc.
- Product
- Frozen Oyster Meat (IQF), Cert No. KR-15-SP; Processor Name:…
- Reason
- Frozen Oyster product is potentially contaminated with Norovirus
- Published
- August 20, 2025
- Distribution
- Distribution is limited to 1 wholesale d…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 7, 2026Historical recordClass II
QST Ingredients and Packaging
- Product
- BBQ Riblet Seasoning (Cargill Meat)(PPM) NET WT: 50 lb UPC (…
- Reason
- Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing.
- Published
- August 20, 2025
- Distribution
- Product was distributed to 4 different c…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 20, 2026Historical recordClass I
Albertsons Companies LLC
- Product
- Randalls MINI SALAD CROISSANT 18 INCH TRAY
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- August 20, 2025
- Distribution
- Jewel Osco products sold in IA, IL, and…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 20, 2026Historical recordClass I
Albertsons Companies LLC
- Product
- READY MEALS TUNA SALAD OVER BED OF LETTUCE
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- August 20, 2025
- Distribution
- Jewel Osco products sold in IA, IL, and…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 20, 2026Historical recordClass I
Albertsons Companies LLC
- Product
- READY MEALS SUSTAINABLE TUNA SALAD CROISSANT SANDWICH
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- August 20, 2025
- Distribution
- Jewel Osco products sold in IA, IL, and…
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 1…
- Reason
- Product label includes the ingredient CREAM but does not include Milk as the source.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.