FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
M.O.M Enterprises, LLC.
- Product
- Organic BABY bedtime drops; sleep + immunity blend; Promotes…
- Reason
- Potential yeast contamination.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lee K of NY Inc.
- Product
- PINOCCHIO CATERING Aged Kimchi Mackerel; 57oz; 27330700000 i…
- Reason
- Product contains undeclared milk and shrimp
- Published
- October 15, 2025
- Distribution
- NY and NJ
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Western United Fish Company Inc
- Product
- Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco #17193…
- Reason
- Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi Tuna Wasabi Poke.
- Published
- October 15, 2025
- Distribution
- Product was sold in the following states…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Egress Capital Partners Inc.
- Product
- Taproom Gourmet brand 18lb bulk "Empire" Mix
- Reason
- No ingredient label. Product contains undeclared allergens (cashews, almonds, walnuts, Brazil nuts, pecans, pistachios)
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Egress Capital Partners Inc.
- Product
- Taproom Gourmet brand 20lb bulk "Park" Mix
- Reason
- No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashews, wheat, soy, and sesame)
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Egress Capital Partners Inc.
- Product
- Taproom Gourmet brand 15lb bulk "Madison" Mix
- Reason
- No ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Egress Capital Partners Inc.
- Product
- Taproom Gourmet brand 15lb bulk "Broadway" Mix
- Reason
- No ingredient label. Product contains undeclared allergens (peanuts, sesame, wheat, and soy)
- Published
- October 15, 2025
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Egress Capital Partners Inc.
- Product
- Taproom Gourmet brand 20lb and 18lb bulk "Fifth Avenue" Mix
- Reason
- No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashew, and soy)
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
by Apotex Corp.
- Reason
- Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- Published
- October 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
by Apotex Corp.
- Reason
- Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- Published
- October 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications.
- Published
- October 8, 2025
- Distribution
- Nationwide
View recall →
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
View recall →
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
View recall →
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
Completed
Historical recordClass II
Vitalabs, Inc.
- Product
- vitamins B12 dietary supplement Raspberry Flavored sold unde…
- Reason
- Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts.
- Published
- October 8, 2025
- Distribution
- Product was shipped to IL & NJ.
View recall →
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
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), 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 →
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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