FDA Recall
Ongoing
Historical recordClass II
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28
by AvKARE
- Reason
- Failed Content Uniformity Specifications
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.
by Acuity Specialty Products, Inc.
- Reason
- cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.
by Acuity Specialty Products, Inc.
- Reason
- cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
by RC Outsourcing, LLC
- Reason
- Lack of assurance of sterility.
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- TAYLOR FARMS COOKED FARFALLE MAP 8 X 3 lb pouches Net Weight…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- FRESH CREATIVE FOODS COOKED FARFALLE PASTA 8 x 3 lb pouches…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Toto Foods, Inc.
- Product
- Toto S'Mores Ooey Gooey Cookie; Gluten Free & Dairy Free; Ne…
- Reason
- Product label contains conflicting statements about inclusion and being free of Soy ingredient.
- Published
- October 15, 2025
- Distribution
- Product was distributed to 6 different r…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- COOKED FETTUCCINE PASTA 6 X 5 lbs pouches Net Weight: 30 lbs…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- TAYLOR FARMS COOKED TROTOLLE MAP 8 X 2.75 lb pouches Net Wei…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- TAYLOR FARMS COOKED ROTINI MAP 8 X 3 lb pouches Net Weight:…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- COOKED LINGUINE PASTA 5LB POUCHES PERISHABLE KEEP REFRIGERAT…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- FRESH CREATIVE FOODS COOKED PENNE PASTA 8 x 3 lb pouches Net…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- MAP COOKED FETTUCCINE PASTA 6 x 5 lbs pouches Net Weight: 30…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Nate's Fine Foods, LLC
- Product
- COOKED LINGUINE PASTA 6 x 5 lb Net Wt. 30lbs (13.60kg) PERIS…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
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
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…
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 →
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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