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 |
|---|---|---|---|---|
| Mar 16, 2020 | Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops ... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11... | Defective Container: Recall is due to breaking and shattering of ampules upon opening | Class I | Dr. Reddy's Laboratories, Inc. |
| Mar 13, 2020 | *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pha... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 13, 2020 | Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by:... | CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... | Class II | Sun Pharmaceutical Industries, Inc. |
| Mar 13, 2020 | C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 13, 2020 | C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Me... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 13, 2020 | *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Ph... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 13, 2020 | Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by:... | CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... | Class II | Sun Pharmaceutical Industries, Inc. |
| Mar 13, 2020 | C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharma... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 11, 2020 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx ... | CGMP Deviations: Presence of dark brown discoloration on edges of tablets | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 10, 2020 | Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with... | Subpotent Drug | Class II | Matthew 7:25 Inc dba Thrive Pharmacy |
| Mar 10, 2020 | Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with... | Subpotent Drug | Class II | Matthew 7:25 Inc dba Thrive Pharmacy |
| Mar 10, 2020 | Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with c... | Subpotent Drug | Class II | Matthew 7:25 Inc dba Thrive Pharmacy |
| Mar 9, 2020 | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharma... | Presence of particulate matter. presence of metal particles. | Class II | Mylan Pharmaceuticals Inc. |
| Mar 9, 2020 | Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.0... | Failed Content Uniformity Specifications: Out Of Specification test results observed for content ... | Class II | Lupin Pharmaceuticals Inc. |
| Mar 9, 2020 | Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and e... | Failed Content Uniformity Specifications: Out Of Specification test results observed for content ... | Class III | Lupin Pharmaceuticals Inc. |
| Mar 9, 2020 | Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactu... | Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of At... | Class II | Sun Pharmaceutical Industries, Inc. |
| Mar 6, 2020 | Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-... | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... | Class II | H J Harkins Company Inc dba Pharma Pac |
| Mar 6, 2020 | Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, ... | CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/... | Class II | Nostrum Laboratories Inc |
| Mar 5, 2020 | Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: ... | CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. | Class II | Fresenius Medical Care Holdings, Inc. |
| Mar 5, 2020 | Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled ... | CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-market... | Class II | Teva Pharmaceuticals USA |
| Mar 4, 2020 | PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par... | Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre... | Class III | Par Pharmaceutical Inc. |
| Mar 3, 2020 | PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g... | Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for ... | Class II | Yusef Manufacturing Laboratories, LLC |
| Mar 2, 2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 ... | Defective Delivery System: Out of specification for mechanical peel and shear. | Class II | Noven Therapeutics, LLC |
| Mar 2, 2020 | Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayn... | Product Mix-Up: A foreign tablet was found in bottle. | Class II | Mayne Pharma Inc |
| Mar 2, 2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 ... | Defective Delivery System: Out of specification for mechanical peel and shear. | Class II | Noven Therapeutics, LLC |
| Mar 2, 2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 ... | Defective Delivery System: Out of specification for mechanical peel and shear. | Class II | Noven Therapeutics, LLC |
| Mar 2, 2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 ... | Defective Delivery System: Out of specification for mechanical peel and shear. | Class II | Noven Therapeutics, LLC |
| Feb 28, 2020 | Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, ... | cGMP Deviation | Class II | Sunstar Guangzhou Ltd. |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distri... | Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The... | Class II | Pfizer Inc. |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 24, 2020 | Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, ... | Lack Of Processing Controls | Class II | Redline Pharmacy Solutions |
| Feb 24, 2020 | Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty... | Lack Of Processing Controls | Class II | Redline Pharmacy Solutions |
| Feb 24, 2020 | Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Sp... | Lack Of Processing Controls | Class II | Redline Pharmacy Solutions |
| Feb 24, 2020 | Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, ... | Lack Of Processing Controls | Class II | Redline Pharmacy Solutions |
| Feb 24, 2020 | Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redl... | Lack Of Processing Controls | Class II | Redline Pharmacy Solutions |
| Feb 24, 2020 | Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 241... | Lack Of Processing Controls | Class II | Redline Pharmacy Solutions |
| Feb 24, 2020 | Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... | Class III | Breckenridge Pharmaceutical, Inc |
| Feb 21, 2020 | Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: A... | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... | Class III | Akorn, Inc. |
| Feb 21, 2020 | Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, D... | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... | Class III | Akorn, Inc. |
| Feb 21, 2020 | CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distribu... | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... | Class III | Akorn, Inc. |
| Feb 20, 2020 | Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... | Failed Dissolution Specifications: Low out of specification dissolution result observed during st... | Class II | Teva Pharmaceuticals USA |
| Feb 19, 2020 | Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, R... | Failed Impurities/Degradation Specification; high out of specification results observed | Class II | Lupin Pharmaceuticals Inc. |
| Feb 17, 2020 | Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count b... | Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chlor... | Class III | Strides Pharma Science Limited |
| Feb 14, 2020 | Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 m... | Labeling: Incorrect or Missing Lot and/or Expiration date. | Class III | AAA Pharmaceutical, Inc. |
| Feb 12, 2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... | Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... | Class II | Lupin Pharmaceuticals Inc. |
| Feb 12, 2020 | TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC ... | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... | Class III | Golden State Medical Supply Inc. |
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.