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
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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: January 9, 2026Historical recordClass II
Jagpreet Enterprises, LLC. dba Sukhi's Gourmet Indian Foods
- Product
- Sukhi's, TIKKA MASALA INDIAN CURRY SAUCE, NET WT 3 OZ., UPC…
- Reason
- Potential contamination with foreign objects (metal pieces).
- Published
- August 20, 2025
- Distribution
- AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 9, 2026Historical recordClass II
Jagpreet Enterprises, LLC. dba Sukhi's Gourmet Indian Foods
- Product
- Sukhi's, CLASSIC CURRY INDIAN CURRY SAUCE, NET WT 3 OZ., UPC…
- Reason
- Potential contamination with foreign objects (metal pieces).
- Published
- August 20, 2025
- Distribution
- AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 9, 2026Historical recordClass II
Jagpreet Enterprises, LLC. dba Sukhi's Gourmet Indian Foods
- Product
- Sukhi's TIKKA MASALA CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11…
- Reason
- Potential contamination with foreign objects (metal pieces).
- Published
- August 20, 2025
- Distribution
- AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 9, 2026Historical recordClass II
Jagpreet Enterprises, LLC. dba Sukhi's Gourmet Indian Foods
- Product
- Sukhi's CLASSIC CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-101,…
- Reason
- Potential contamination with foreign objects (metal pieces).
- Published
- August 20, 2025
- Distribution
- AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL,…
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 →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 25, 2026Historical recordClass III
Enjoy Nutrition, LLC; dba Weyland Brain Nutrition
- Product
- Lithium Orotate, 5MG, 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
TerminatedTerminated: September 11, 2025Historical recordClass II
Superior Foods Company
- Product
- Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in pla…
- Reason
- foreign material (plastic)
- Published
- August 20, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence of foreign substance: identified as aluminum.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
by Cardinal Health Inc.
- Reason
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
by Cardinal Health Inc.
- Reason
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
by Cardinal Health Inc.
- Reason
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
by Direct Rx
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- August 13, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
by Direct Rx
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Published
- August 13, 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.
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