Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 301–320 of 1,000 recalls

Class IITerminated

Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →
Class IITerminated

CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · Drug
View details →
Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →
Class IITerminated

CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →
Class IITerminated

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

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →
Class IITerminated

Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →
Class IITerminated

EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →
Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →
Class IITerminated

Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

TMC Acquisitions LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

August 15, 2023 · DrugView details →
Class IITerminated

NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.

TMC Acquisitions LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

August 15, 2023 · DrugView details →
Class IITerminated

Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478

AVKARE LLC

Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

August 11, 2023 · DrugView details →
Class IITerminated

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

Baxter Healthcare Corporation

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

August 11, 2023 · DrugView details →
Class IITerminated

Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478

AVKARE LLC

Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

August 11, 2023 · DrugView details →
Class IITerminated

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.

Baxter Healthcare Corporation

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

August 11, 2023 · DrugView details →
Class IITerminated

hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case).

Colgate Palmolive Company

Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.

August 10, 2023 · DrugView details →
Class IITerminated

Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004

Parker Laboratories, Inc.

CGMP Deviations

August 2, 2023 · DrugView details →
Class IITerminated

Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

Parker Laboratories, Inc.

CGMP Deviations

August 2, 2023 · DrugView details →
Class IITerminated

Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004

Parker Laboratories, Inc.

CGMP Deviations

August 2, 2023 · DrugView details →
Class IITerminated

Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

Aurobindo Pharma USA Inc.

Failed dissolution specifications - results obtained were below spec average.

August 2, 2023 · DrugView details →
Class IITerminated

Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

Parker Laboratories, Inc.

CGMP Deviations

August 2, 2023 · DrugView details →
← PreviousPage 16 of 50Next →