FDA Recall
Ongoing
Historical recordClass II
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
by Ascend Laboratories, LLC
- Reason
- Failed Impurities/Degradation Specification: Out of specification for organic impurities
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.
by Lupin Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or Missing Package Insert
- Published
- February 28, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
by Baxter Healthcare Corporation
- Reason
- Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
- Published
- February 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), 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 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
Terminated
Historical recordClass II
Mennel Milling Company
- Product
- PIZZA 50/50 UNMALTED 904181 delivered as bulk product in app…
- Reason
- Potential Foreign Material - Metal, Wood, Gasket Material, and/or Sifter balls
- Published
- February 28, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mennel Milling Company
- Product
- PB AP delivered as bulk product in approximately 50,000 lbs…
- Reason
- Potential Foreign Material - Metal, Wood, Gasket Material, and/or Sifter balls
- Published
- February 28, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mennel Milling Company
- Product
- NON-HUMAN CONSUMPTION delivered as bulk product in approxima…
- Reason
- Potential Foreign Material - Metal, Wood, Gasket Material, and/or Sifter balls
- Published
- February 28, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mennel Milling Company
- Product
- I-52 PATENT FLOUR delivered as bulk product in approximately…
- Reason
- Potential Foreign Material - Metal, Wood, Gasket Material, and/or Sifter balls
- Published
- February 28, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mennel Milling Company
- Product
- HARD WHEAT 2ND CLEAR delivered as bulk product in approximat…
- Reason
- Potential Foreign Material - Metal, Wood, Gasket Material, and/or Sifter balls
- Published
- February 28, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mennel Milling Company
- Product
- PIZZA FLOUR EN MA BL delivered as bulk product in approximat…
- Reason
- Potential Foreign Material - Metal, Wood, Gasket Material, and/or Sifter balls
- Published
- February 28, 2024
- Distribution
- Multiple states
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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