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Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,152 FDA drug recalls in 2021.

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DateProductReasonClassFirm
Dec 6, 2021 Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Singl... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% ... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single ... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmi... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syring... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Prese... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, ... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / ... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single D... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Singl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Dexamethasone sodium phosphate, sterile otic solution for injection Preservat... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Ph... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropp... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dro... Lack of Assurance of Sterility. Class II Edge Pharma, LLC
Dec 6, 2021 kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... Class I Valisa MFG LLC
Dec 3, 2021 Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of... Class I Gilead Sciences, Inc.
Dec 3, 2021 Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape... Lack of Processing Controls Class II Valgene Incorporated dba Cape Drugs
Dec 3, 2021 CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Ro... Lack of Processing Controls Class II Valgene Incorporated dba Cape Drugs
Dec 3, 2021 CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodi... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bo... Labeling: Missing Label Class III Akorn, Inc.
Dec 3, 2021 CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx o... Labeling: Missing Label Class III Akorn, Inc.
Dec 3, 2021 CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neut... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluor... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 2, 2021 Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufa... Failed Dissolution Specifications Class II Torrent Pharma Inc.
Dec 1, 2021 Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bot... Superpotent; Hydrochlorothiazide Class III Torrent Pharma Inc.
Nov 30, 2021 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... Lack of sterility assurance: bag has the potential to leak. Class II Pfizer Inc.
Nov 30, 2021 Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... Superpotent Drug Class I Teligent Pharma, Inc.
Nov 30, 2021 Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... Superpotent Drug: Minimally superpotent Class II Teligent Pharma, Inc.
Nov 30, 2021 Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methan... Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... Class I Aroma Release Technologies Inc
Nov 29, 2021 PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate... CGMP Deviations: failed stability results, inadequate laboratory investigations, Class II ULTRAtab Laboratories, Inc.
Nov 29, 2021 Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx ... Defective container: Out of specification for container integrity leading to bottles leaking. Class II Preferred Pharmaceuticals, Inc.
Nov 29, 2021 Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, ... Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5... Class II Denver Solutions, LLC DBA Leiters Health

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.