FDA Recall
Ongoing
Historical recordClass I
Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
by Neptune Resources, LLC
- Reason
- Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
by Neptune Resources, LLC
- Reason
- Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
by Bestco LLC
- Reason
- CGMP Deviations: Potential Glass and Silicone particulates in product
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification test results.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
by Apotex Corp.
- Reason
- CGMP Deviations: potential presence of Burkholderia cepacia complex
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Meta Psyllium Fiber Capsules packaged as 100 count or 160 co…
- Reason
- Illegible Label
- Published
- February 28, 2024
- Distribution
- Alabama, Arizona, Arkansas, California,…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
New World Company
- Product
- Fortune cookies, individually wrapped in a 6lb case, 190 pcs…
- Reason
- Undeclared allergens (soy)
- Published
- February 28, 2024
- Distribution
- Products are distributed from wholesale…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
New World Company
- Product
- Fortune cookies, 1 lb plastic retail bags
- Reason
- Undeclared allergens (soy)
- Published
- February 28, 2024
- Distribution
- Products are distributed from wholesale…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
New World Company
- Product
- Bulk case of Fortune cookies, labeled as 6 lb (1.3 lb per ba…
- Reason
- Undeclared allergens (wheat and soy)
- Published
- February 28, 2024
- Distribution
- Products are distributed from wholesale…
View recall →
FDA Recall
Terminated
Historical recordClass II
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
- Published
- February 21, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
by Teva Pharmaceuticals USA, Inc
- Reason
- Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Published
- February 21, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
by Teva Pharmaceuticals USA, Inc
- Reason
- Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Published
- February 21, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fresh Express Incorpated
- Product
- Fresh Express Kit Salsa! Ensalada with condiments(toppings t…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by the cheese supplier.
- Published
- February 21, 2024
- Distribution
- AL, FL, GA, CA, UT, WA; Canada
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fresh Express Incorpated
- Product
- Chopped Salad Kit Southwest with condiments(toppings that in…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by the cheese supplier.
- Published
- February 21, 2024
- Distribution
- AL, FL, GA, CA, UT, WA; Canada
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
AMY'S KITCHEN INC.
- Product
- Gluten Free Bean and Cheese Burrito (5.5 oz), individual pla…
- Reason
- Presence of foreign material in food (plastic)
- Published
- February 21, 2024
- Distribution
- Products are distributed to distributors…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
UNFI General Corporate
- Product
- Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Gol…
- Reason
- The ingredient Triticale is not identified as wheat.
- Published
- February 21, 2024
- 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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