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Drugs Recalls

17,897 recalls, newest first.

February 9, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufa
Hazard: Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
February 2, 2022DrugsFDA
Dental Alliance Holdings LLC recalls CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g
Hazard: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
February 2, 2022DrugsFDA
Dental Alliance Holdings LLC recalls CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx on
Hazard: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
February 2, 2022DrugsFDA
Dental Alliance Holdings LLC recalls CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 6
Hazard: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
February 2, 2022DrugsFDA
Dental Alliance Holdings LLC recalls CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 6
Hazard: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
February 2, 2022DrugsFDA
Dental Alliance Holdings LLC recalls CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC:
Hazard: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
February 2, 2022DrugsFDA
Dental Alliance Holdings LLC recalls CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-20
Hazard: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
February 2, 2022DrugsFDA
Dental Alliance Holdings LLC recalls CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral Bio
Hazard: Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
February 2, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx O
Hazard: cGMP deficiencies
February 2, 2022DrugsFDA
American Health Packaging recalls Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories
Hazard: Failed Dissolution Specifications
February 2, 2022DrugsFDA
Aurobindo Pharma USA Inc. recalls Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC
Hazard: Superpotent and Failed Tablet/Capsule Specifications
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, F
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, E
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC,
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-M
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Co
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Mu
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC,
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., C
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr,
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 H
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30
Hazard: CGMP Deviations
February 2, 2022DrugsFDA
Edge Pharma, LLC recalls CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 cou
Hazard: CGMP Deviations