FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Hillside Orchard Farms Inc.
- Product
- Blueberry Bread Net Wt. 23 oz (652 G) CONTAINS: MILK, SOY, &…
- Reason
- Undeclared egg.
- Published
- August 27, 2025
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Hillside Orchard Farms Inc.
- Product
- Fresh Blackberry Bread Net Wt. 23 oz (652 G) CONTAINS: MILK,…
- Reason
- Undeclared egg.
- Published
- August 27, 2025
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Hillside Orchard Farms Inc.
- Product
- Banana Nut Bread Net. Wt 23 oz (653g) CONTAINS: MILK, SOY, W…
- Reason
- Undeclared egg.
- Published
- August 27, 2025
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Hillside Orchard Farms Inc.
- Product
- Apple Fritter Contains: Wheat, Soy and Milk Made By: Hillsid…
- Reason
- Undeclared egg.
- Published
- August 27, 2025
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Hillside Orchard Farms Inc.
- Product
- Fresh Apple Bread Net Wt 23 oz (652g) CONTAINS: MILK, SOY, &…
- Reason
- Undeclared egg.
- Published
- August 27, 2025
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)
by Merck & Co. Inc
- Reason
- Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metoprolol Tartrate Tablets, USP, 50 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 69367-354-10
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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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 →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9
- Reason
- Product label includes the ingredient CREAM but does not include Milk as the source.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC:…
- 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.