Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 6, 2021 | Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injecti... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose C... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg... | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... | Class II | Medique Products |
| Dec 6, 2021 | Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Mul... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Sing... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphoteri... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), ... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ... | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... | Class II | Medique Products |
| Dec 6, 2021 | Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 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 | 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 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 | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... | Superpotent Drug | Class I | Teligent 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 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 |
| 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 | 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 23, 2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, To... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deod... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily,... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, ... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Esse... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topica... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chl... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deo... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Pro... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, To... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash ... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Ant... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, ... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
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.