FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Twin City Foods, Inc.
- Product
- Individually Quick Frozen (IQF) Corn, distributed in bulk ca…
- Reason
- Listeria monocytogenes
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Twin City Foods, Inc.
- Product
- Individually Quick Frozen (IQF) Corn distributed in BULK TOT…
- Reason
- Listeria monocytogenes
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
by Marlex Pharmaceuticals, Inc.
- Reason
- Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
by Marlex Pharmaceuticals, Inc.
- Reason
- Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fosfomycin Tromethamine Granules for Oral Solution, 3 g 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 Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10
by Caplin Steriles Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
by Esperion
- Reason
- Failed dissolution specifications: below specification results at stability 12-month
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
by APG SEVEN, INC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
by Lundbeck LLC
- Reason
- Cross contamination with other products
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL 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
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60
by Contract Pharmaceuticals Limited Canada
- Reason
- Defective Container: slow leakage under the cap
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Published
- September 6, 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.
Read the full medical disclaimer.