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
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 →
FDA Recall
🇺🇸 United States
OngoingHistorical 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
OngoingHistorical 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 →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UP…
- 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
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC…
- 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
TerminatedTerminated: March 25, 2026Historical recordClass III
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
- Product
- Lithium Orotate, 20MG, Distributed by Enjoy Nutrition, LLC.…
- Reason
- Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 25, 2026Historical recordClass III
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
- Product
- Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC.…
- Reason
- Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 25, 2026Historical recordClass III
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
- Product
- Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC. U…
- Reason
- Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
- Published
- August 20, 2025
- Distribution
- Nationwide
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 →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-820…
- 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
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82…
- 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
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-0310…
- 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
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-6…
- 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
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-…
- 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
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-6…
- 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
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Strawberry Con Crema Single Serve Paleta 3.75o…
- 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
OngoingHistorical recordClass II
Tropicale Foods, LLC
- Product
- La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz U…
- 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
TerminatedTerminated: March 25, 2026Historical recordClass III
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
- Product
- Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC.…
- Reason
- Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
- 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.