FDA Recall
OngoingHistorical recordClass II
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
by FDC Limited
- Reason
- Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 16, 2025Historical recordClass I
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
by Endo Pharmaceuticals, Inc.
- Reason
- Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
by SoloVital
- Reason
- Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 11, 2025Historical recordClass II
Urban Outfitters Inc.
- Product
- Elin Dessert Plates. The recalled plates are lilac in color…
- Reason
- Elevated levels of cadmium in plates
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Abilyn's Frozen Bakery Cookie Dough Ice Cream UPC 8515450080…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Vanilla Bean 16 fl oz/1 pint, UPC 857838006168. Pac…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Swiss Chocolate 16 fl oz/1 pint, UPC 857838006342.…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Stracciatella Gelato 16 fl oz/1 pint, UPC 857838006…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Peanut Butter Stracciatella Gelato 16 fl oz/1 pint,…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Peanut Butter Cup Gelato 16 fl oz/1 pint, UPC 85783…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Roasted Strawberry Gelato 16 fl oz/1 pint, UPC 8578…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Mascarpone & Berries Gelato 16 fl oz/1 pint, UPC 85…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Dulce de Leche & Cookies Gelato 16 fl oz/1 pint, U…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Dark Chocolate Gelato 16 fl oz/1 pint, UPC 85783800…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Coffee & Cookies Gelato 16 fl oz/1 pint, UPC 857838…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Dark Chocolate Fudge Gelato 16 fl oz/1 pint, UPC 85…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Hot Cocoa Gelato 16 fl oz/1 pint, UPC 857838006610.…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 8, 2024Historical recordClass II
Totally Cool, Inc.
- Product
- Dolcezza Sugar Cookie Dough Gelato 16 fl oz/1 pint, UPC 8578…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- August 7, 2024
- 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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