FDA Recall
Completed
Historical recordClass II
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Published
- May 3, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
by Wellness BioSciences
- Reason
- Marketed Without an Approved NDA/ANDA
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
by Methapharm Inc
- Reason
- CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
- Published
- May 3, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Mondi Lamex Serbia
- Product
- Savor Imports IQF Whole Raspberries; Net Wt 2-5lb; MFG# 3417…
- Reason
- Potential contamination with Hepatitis A
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
by Ascend Laboratories, LLC
- Reason
- Out of specification (OOS) for Spectroscopic Identification test by IR.
- Published
- April 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.
by Pharma Nobis LLC
- Reason
- CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
- Published
- April 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications: Out of specification dissolution results above specified values.
- Published
- April 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Kar Nut Products Company
- Product
- Sheila G's Gluten Free Reese's Pieces Brownie Brittle, 4 oz…
- Reason
- Product is labeled "Gluten Free" but may contain undeclared wheat.
- Published
- April 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Natural Solutions Foundation
- Product
- Dr. Rima Recommends The Silver Solution Immune System Suppor…
- Reason
- Product labeled and intended to mitigate, prevent, or treat COVID-19
- Published
- April 26, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13
by Focus Health Group Inc
- Reason
- Labeling; Incorrect NDC number on outer carton of product.
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
by Pfizer Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary packaging consists of a coated cardboard box, with order-specific label indicating lot number housed within order/container. NDC # 69194-0458-1
by Pine Pharmaceuticals, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
by Hetero USA Inc
- Reason
- CGMP Deviations: Discoloration
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wellness Natural USA Inc.
- Product
- SimplyProtein¿ Peanut Butter Chocolate Crispy 15-1.41 OZ (40…
- Reason
- Undeclared cashew
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
E S Foods
- Product
- 61118C Apple Jacks BB
- Reason
- Animal Crackers in Meal Kits may contain metal shavings (bronze)
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
E S Foods
- Product
- 65550 5 Days Meal Kit
- Reason
- Animal Crackers in Meal Kits may contain metal shavings (bronze)
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
E S Foods
- Product
- 61288 Mini Animal Graham Cinnamon SB
- Reason
- Animal Crackers in Meal Kits may contain metal shavings (bronze)
- Published
- April 19, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
E S Foods
- Product
- 61250 Trix Cereal Bar BB
- Reason
- Animal Crackers in Meal Kits may contain metal shavings (bronze)
- Published
- April 19, 2023
- 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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