FDA Recall
🇺🇸 United States
Terminated
Historical 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
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
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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
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
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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
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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
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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
Terminated
Historical recordClass II
Tas Tematic Foods Inc
- Product
- Frozen Raw Easy Peel shrimp, IQF, 2-lb bag, 10 bags/case; Ge…
- Reason
- Product which was on FDA hold for high levels of Nitrofuran was inadvertently distributed.
- Published
- October 8, 2025
- Distribution
- Product was distributed to two (2) locat…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lawrence Wholesale LLC
- Product
- 16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear p…
- Reason
- Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Published
- October 8, 2025
- Distribution
- Product was distributed to Kroger stores…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lawrence Wholesale LLC
- Product
- Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UP…
- Reason
- Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Published
- October 8, 2025
- Distribution
- Product was distributed to Kroger stores…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Lipton Green Tea Citrus. 16.9 ounce PET Bottle. sold as 12pk…
- Reason
- Undeclared sugar in finished product-primary package does not reflect the product inside bottle.
- Published
- October 8, 2025
- Distribution
- Products distributed in the following st…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
WFM Purchasing, LP
- Product
- Whole Foods Market Blueberry Almond Granola, PLU 86032, pack…
- Reason
- Product was incorrectly labeled, resulting in undeclared wheat, sesame, and cashew.
- Published
- October 8, 2025
- Distribution
- One retail store in Philadelphia, PA.
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
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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 →
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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