FDA Recall
Ongoing
Historical recordClass II
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- Published
- October 8, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- Published
- October 8, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
GOOT ESSA, LLC
- Product
- Goot Essa, Der Mutterschaf Cheese, Sheep Tomme Style. 4 and…
- Reason
- The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.
- Published
- October 8, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Gina Marie Bakery LLC
- Product
- Toasted Cherry Biscotti
- Reason
- Contains undeclared Red 40
- Published
- October 8, 2025
- Distribution
- Firm notified FDA of recall initiated by…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Gina Marie Bakery LLC
- Product
- Vanilla Cookies with Raspberry Peach Jam
- Reason
- Undeclared Red 3 and Blue 1
- Published
- October 8, 2025
- Distribution
- Firm notified FDA of recall initiated by…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Gina Marie Bakery LLC
- Product
- Toasted Almond & Cherry Biscotti
- Reason
- Undeclared Red 40
- Published
- October 8, 2025
- Distribution
- Firm notified FDA of recall initiated by…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Gina Marie Bakery LLC
- Product
- Vanilla with Apricot Jam Cookies
- Reason
- Undeclared Red 40 and Yellow 6
- Published
- October 8, 2025
- Distribution
- Firm notified FDA of recall initiated by…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Gina Marie Bakery LLC
- Product
- Vanilla Chocolate Dipped Cookies
- Reason
- Undeclared Red 40
- Published
- October 8, 2025
- Distribution
- Firm notified FDA of recall initiated by…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Gina Marie Bakery LLC
- Product
- Italian Sesame Cookies
- Reason
- Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6
- Published
- October 8, 2025
- Distribution
- Firm notified FDA of recall initiated by…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Gina Marie Bakery LLC
- Product
- Italian Mixed Vanilla Cookies
- Reason
- Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1
- Published
- October 8, 2025
- Distribution
- Firm notified FDA of recall initiated by…
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FDA Recall
Ongoing
Historical recordClass III
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
by Medline Industries, LP
- Reason
- Subpotent drug
- Published
- October 1, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, 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: Market complaints received for gritty texture (grainy)
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
by Consumer Product Partners, LLC
- Reason
- Cross Contamination with Other Products.
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
by Consumer Product Partners, LLC
- Reason
- Cross Contamination with Other Products.
- Published
- October 1, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Gooder Foods, Inc.
- Product
- GOODLES HERE COMES TRUFFLE CREAMY TRUFFLE FLAVORED CHEDDAR A…
- Reason
- Undeclared allergens (cashews).
- Published
- October 1, 2025
- Distribution
- Foreign Distribution: Canada U.S. Distr…
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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