Drug and pharmaceutical recalls

17623 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2023-07-05FDA-DrugHomeocare Laboratories, Inc.Class II
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
cGMP deviations
2023-07-05FDA-DrugHomeocare Laboratories, Inc.Class II
Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01
cGMP deviations
2023-07-05FDA-DrugHomeocare Laboratories, Inc.Class II
Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
cGMP deviations
2023-07-05FDA-DrugHomeocare Laboratories, Inc.Class II
Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
cGMP deviations
2023-07-05FDA-DrugHomeocare Laboratories, Inc.Class II
Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02
cGMP deviations
2023-07-05FDA-DrugFerring Pharmaceuticals IncClass II
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
2023-07-05FDA-DrugThe Harvard Drug GroupClass II
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
Packaging defect: blister packaging inadequately sealed.
2023-06-28FDA-DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesClass I
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
2023-06-28FDA-DrugAurolife Pharma, LLCClass III
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Failed Impurities/Degradation Specifications
2023-06-21FDA-DrugAmneal Pharmaceuticals of New York, LLCClass II
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
2023-06-21FDA-DrugAVKARE LLCClass III
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
2023-06-21FDA-DrugJarman's Midwest Cleaning Systems, Inc.Class I
SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
Chemical Contamination: FDA testing found Presence of methanol
2023-06-21FDA-DrugJarman's Midwest Cleaning Systems, Inc.Class I
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
Chemical Contamination: FDA testing found Presence of methanol
2023-06-21FDA-DrugJarman's Midwest Cleaning Systems, Inc.Class II
Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
2023-06-21FDA-DrugAmring Pharmaceuticals IncClass III
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
2023-06-14FDA-DrugHF Acquisition Co LLCClass III
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Labeling: Label Mix-up
2023-06-14FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass II
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
CGMP Deviations
2023-06-14FDA-DrugGolden State Medical Supply Inc.Class II
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
2023-06-14FDA-DrugViatris IncClass II
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
2023-06-14FDA-DrugEmpower Clinic Services LLC dba Empower PharmacyClass II
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
Mislabeling: preservative free product labeled as preserved.
2023-06-07FDA-DrugNovis PR, LLC dba Kramer NovisClass I
G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
2023-06-07FDA-DrugAkorn, Inc.Class II
Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.

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