FDA Recall
🇺🇸 United States
TerminatedTerminated: April 20, 2026Historical recordClass III
DEMERS FOOD GROUP LLC
- Product
- Scott & Jon s Honey Sesame Salmon Rice Bowl
- Reason
- contains undeclared wheat
- Published
- October 15, 2025
- Distribution
- Florida, Georgia, Maryland, Massachusett…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 23, 2025Historical recordClass I
Harris Teeter
- Product
- Harris Teeter ASIAGO TEXAS TOAST, NET WT 5.0OZ (0.3lb), INGR…
- Reason
- Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.
- Published
- October 15, 2025
- Distribution
- Product was sold in the following states…
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FDA Recall
🇺🇸 United States
OngoingHistorical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 25, 2025Historical 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
TerminatedTerminated: January 16, 2026Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 16, 2026Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 16, 2026Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 16, 2026Historical 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
TerminatedTerminated: January 16, 2026Historical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
OngoingHistorical 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
OngoingHistorical 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
OngoingHistorical 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
OngoingHistorical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
OngoingHistorical 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 →
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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