Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-10-09FDA-DrugColonia Care PharmacyClass IIC-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
- 2019-10-09FDA-DrugColonia Care PharmacyClass IIC-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
- 2019-10-09FDA-DrugColonia Care PharmacyClass IIC-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
- 2019-10-09FDA-DrugColonia Care PharmacyClass IIC-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
- 2019-10-09FDA-DrugColonia Care PharmacyClass IIC-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
- 2019-10-09FDA-DrugColonia Care PharmacyClass IIC-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
- 2019-10-02FDA-DrugJohnson Matthey Inc.Class IIOxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
cGMP Deviations: Potential glass contamination
- 2019-10-02FDA-DrugJohnson Matthey Inc.Class IICisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
cGMP Deviations: Potential glass contamination
- 2019-10-02FDA-DrugJohnson Matthey Inc.Class IIFentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.
cGMP Deviations: Potential glass contamination
- 2019-10-02FDA-DrugAkorn, Inc.Class IILidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
- 2019-10-02FDA-DrugPreferred Pharmaceuticals, IncClass IIFexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
Failed Impurities/Degradation Specifications
- 2019-10-02FDA-DrugCardinal Health dba Specialty Pharmaceutical ServicesClass IINucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42.
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
- 2019-10-02FDA-DrugDarmerica, LLCClass IQuinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
- 2019-10-02FDA-DrugEPI Health, LLCClass IIIminolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.
Failed Dissolution Specifications:
- 2019-10-02FDA-DrugShire Human Genetic Therapies, Inc.Class INatpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
- 2019-10-02FDA-DrugShire Human Genetic Therapies, Inc.Class INatpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
- 2019-10-02FDA-DrugShire Human Genetic Therapies, Inc.Class INatpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
- 2019-10-02FDA-DrugShire Human Genetic Therapies, Inc.Class INatpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
- 2019-10-02FDA-DrugPfizer Inc.Class IIIZarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
- 2019-10-02FDA-DrugPfizer Inc.Class IIICheck your ethosuximide capsules expiration date
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIAllergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIWal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIAllergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIFexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIFexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIAllergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIFexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIfexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIAllergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.
Failed Impurities/Degradation Specifications
- 2019-09-25FDA-DrugAurolife Pharma, LLCClass IIAllergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.
Failed Impurities/Degradation Specifications
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