Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 10, 2022 | Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50)... | CGMP Deviations | Class II | Ingenus Pharmaceuticals Llc |
| Dec 30, 2021 | Metformin 750 mg Extended Release NDC # 70518-2920-00 | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | RemedyRepack Inc. |
| Dec 27, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE ... | CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | VIONA PHARMACEUTICALS INC |
| 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 | Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Mul... | 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 | LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose C... | 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 | 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 | Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injecti... | CGMP Deviations | Class II | Edge Pharma, LLC |
| 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 | Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per... | CGMP Deviations | 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 | Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... | CGMP Deviations | 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 | Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe... | CGMP Deviations | 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 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% ... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial ... | CGMP Deviations | 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 | 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 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% /... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID),... | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... | Class II | Medique Products |
| 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 | Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocor... | CGMP Deviations | 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 | Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Contain... | CGMP Deviations | Class II | Edge Pharma, LLC |
| 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 | 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 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 | 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 | 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 | 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 | 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, 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, 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 |
| 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, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, C... | 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, ... | 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 1, 2021 | Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup... | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Class II | Precision Dose Inc. |
| Nov 1, 2021 | Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Ind... | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Class II | Precision Dose Inc. |
| Oct 26, 2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL O... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 26, 2021 | Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 ... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
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.