FDA Recall
Ongoing
Historical recordClass I
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
by NSNY Distributor Inc
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by Japan Portobello, Mushrooms, Sweet Pota…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by India Curry, Broccoli, Cauliflower, Coc…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by Mexico Roasted Poblanos, Ancho Chilli P…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by America Roasted Potato, Dill, Chives, R…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
by VIONA PHARMACEUTICALS INC
- Reason
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
by Bausch Health Companies, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
by Bausch Health Companies, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20
by Hill Dermaceuticals, Inc.
- Reason
- Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- Presence of Foreign Substance: Foreign particles observed during routine stability testing.
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
by Miracle 8989
- Reason
- Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
by Miracle 8989
- Reason
- Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
by Miracle 8989
- Reason
- Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
- Published
- June 30, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Concord Farms
- Product
- Concord Farms Fresh Enoki Mushrooms; 5.25 oz. (150g) or 7 o…
- Reason
- California Department of Public Health sampled Concord Farms Enoki Mushrooms which were positive for Listeria monocytogenes.
- Published
- June 30, 2021
- Distribution
- U.S. distribution to the following: CA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Banner Smoked Fish Inc.
- Product
- Banner Smoked Fish Inc., brand Large Smoked Chubs
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- June 30, 2021
- Distribution
- NY, NJ, IL, PA, CA, FL, NE, AZ, MA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Banner Smoked Fish Inc.
- Product
- Banner Smoked Fish Inc. brand Hot Smoked Ground Kingfish Mea…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- June 30, 2021
- Distribution
- NY, NJ, IL, PA, CA, FL, NE, AZ, MA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Banner Smoked Fish Inc.
- Product
- Banner Smoked Fish Inc. brand Hot-Smoked Ground Amberjack me…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- June 30, 2021
- Distribution
- NY, NJ, IL, PA, CA, FL, NE, AZ, MA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Banner Smoked Fish Inc.
- Product
- Banner Smoked Fish Inc. brand Sliced Smoked Escolar; Ingredi…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- June 30, 2021
- Distribution
- NY, NJ, IL, PA, CA, FL, NE, AZ, MA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Banner Smoked Fish Inc.
- Product
- Banner Smoked Fish Inc. brand Smoked Brook Trout; Ingredient…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- June 30, 2021
- Distribution
- NY, NJ, IL, PA, CA, FL, NE, AZ, MA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Banner Smoked Fish Inc.
- Product
- a.) Supreme Fine Fish Products brand Fresh Sliced Sable; Ing…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- June 30, 2021
- Distribution
- NY, NJ, IL, PA, CA, FL, NE, AZ, MA, MD,…
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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