FDA Recall
Terminated
Historical recordClass II
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
by Sun Pharmaceutical Industries Ltd.
- Reason
- Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
by SCA Pharmaceuticals
- Reason
- Subpotent Drug: Out of specification results for low potency was obtained.
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
by Northwind Pharmaceuticals LLC
- Reason
- CGMP Deviations
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
by DuPont Nutrition USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
by DuPont Nutrition USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
by DuPont Nutrition USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
by DuPont Nutrition USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- May 3, 2023
- Distribution
- Nationwide
View recall →
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
View recall →
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
View recall →
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 →
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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