FDA Recall
Ongoing
Historical recordClass II
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
by MEDLINE INDUSTRIES, LP - Northfield
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Published
- September 3, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
by MEDLINE INDUSTRIES, LP - Northfield
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Published
- September 3, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
by Lannett Company Inc.
- Reason
- Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
- Published
- September 3, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
by Amerisource Health Services LLC
- Reason
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Published
- September 3, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
by Baxter Healthcare Corporation
- Reason
- Discoloration
- Published
- September 3, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
The J.M. Smucker Company
- Product
- Hostess Ding Dongs CHOCOLATE CAKE WITH CREAMY FILLING 2.55 o…
- Reason
- Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.
- Published
- September 3, 2025
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CHETAK NEW YORK LLC
- Product
- Deep Sprouted Moong 16 oz
- Reason
- Product tested positive Salmonella .
- Published
- September 3, 2025
- Distribution
- Th recalled product was distributed to t…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CHETAK NEW YORK LLC
- Product
- Deep Sprouted Mat 16 oz.
- Reason
- Product tested positive Salmonella .
- Published
- September 3, 2025
- Distribution
- Th recalled product was distributed to t…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Bakers Authority LLC
- Product
- Baker's Authority Graham Cracker Meal; 5lb bag; stored dry a…
- Reason
- Product label does not list ingredients including major food allergens: wheat and soy (vegetable oil). Additional undeclared ingredients include: niacin, reduced iron, vitamin B1, vitamin B2, invert sugar
- Published
- September 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Bakers Authority LLC
- Product
- Baker's Authority Everything Bagel Mix; 5lb bag and 1lb bag;…
- Reason
- Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: poppy seeds, dried garlic, dried onion, and sea salt
- Published
- September 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Bakers Authority LLC
- Product
- Baker's Authority Three Seed Mix; 5lb bag; stored dry at roo…
- Reason
- Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: millet and flax
- Published
- September 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Breadbox Co.
- Product
- Breadman Bakery; Multigrain 24oz. Baked for Breaman-Melrose…
- Reason
- Finished product label does not include allergen ingredient Sesame Seed.
- Published
- September 3, 2025
- Distribution
- product was distributed to 7 retail loca…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gelsons
- Product
- Gelson's Hummus; Red Bell Pepper Old World Family Recipe Cal…
- Reason
- Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"
- Published
- September 3, 2025
- Distribution
- Product is own label brand only distribu…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gelsons
- Product
- Gelson's Hummus; Mediterranean Old World Family Recipe Calif…
- Reason
- Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"
- Published
- September 3, 2025
- Distribution
- Product is own label brand only distribu…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gelsons
- Product
- Gelson's Hummus; Low Sodium No Cholesterol Classic NET WT 10…
- Reason
- Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"
- Published
- September 3, 2025
- Distribution
- Product is own label brand only distribu…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gelsons
- Product
- Gelson's Tzatziki; Old-World Family Recipe Real Greek Yogurt…
- Reason
- Gelson branded Tzatziki sauce product labels do not include storage instructions "keep refrigerated"
- Published
- September 3, 2025
- Distribution
- Product is own label brand only distribu…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
by VIONA PHARMACEUTICALS INC
- Reason
- Discoloration
- Published
- August 27, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Published
- August 27, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
by Cipla USA, Inc.
- Reason
- Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
- Published
- August 27, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
by Haleon US Holdings LLC
- Reason
- Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
- Published
- August 27, 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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