Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 25, 2019 | Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx... | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Class II | Macleods Pharma Usa Inc |
| Feb 25, 2019 | Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, ... | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Class II | Macleods Pharma Usa Inc |
| Feb 22, 2019 | Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per pac... | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutrami... | Class I | Golean Detox US |
| Feb 22, 2019 | Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manu... | Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individ... | Class II | Akorn, Inc. |
| Feb 22, 2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... | Class II | Ascend Laboratories LLC |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6m... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Profes... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile inje... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 coun... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | Macleods Pharma Usa Inc |
| Feb 21, 2019 | HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml inj... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only... | Failed Dissolution Specifications | Class III | Lannett Company Inc. |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Profession... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compoundin... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Profe... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professio... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Profes... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compoundi... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Pro... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional C... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Profe... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, P... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Com... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Comp... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Profes... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professio... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional ... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Profess... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professiona... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 20, 2019 | Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Ag... | Cross Contamination: Presence of IPA in finished product. | Class II | Vi-Jon, Inc. |
| Feb 19, 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05)... | Failed dissolution specifications | Class III | Amerigen Pharmaceuticals Inc. |
| Feb 19, 2019 | Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL... | Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead ... | Class II | Leiter's Enterprises, Inc. |
| Feb 19, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-31... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | American Health Packaging |
| Feb 15, 2019 | Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only,... | Subpotent Drug. | Class II | Heritage Pharmaceuticals, Inc. |
| Feb 14, 2019 | Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL... | Presence of Particulate Matter: Particulates observed in vials release for dispensing. | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Feb 13, 2019 | Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, ... | Failed Degradation/Impurities Specifications: Out of specification related substance results duri... | Class III | Perrigo New York, Inc. |
| Feb 13, 2019 | White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) ... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Class I | Todd Holiday dba Sunstone Organics |
| Feb 13, 2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count ... | Failed Impurities/Degradation Specifications: High out of specification results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Feb 13, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and ... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | Lupin Pharmaceuticals Inc. |
| Feb 13, 2019 | White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 ... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Class I | Todd Holiday dba Sunstone Organics |
| Feb 13, 2019 | Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Class I | Todd Holiday dba Sunstone Organics |
| Feb 13, 2019 | Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gr... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Class I | Todd Holiday dba Sunstone Organics |
| Feb 8, 2019 | MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use b... | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (... | Class II | Avella of Deer Valley, Inc. Store 38 |
| Feb 8, 2019 | Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel L... | Unapproved new drug | Class II | McDaniel Life-Line LLC |
| Feb 8, 2019 | MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use ... | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (... | Class II | Avella of Deer Valley, Inc. Store 38 |
| Feb 8, 2019 | MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Com... | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional (... | Class II | Avella of Deer Valley, Inc. Store 38 |
| Feb 8, 2019 | Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint,... | Unapproved new drug | Class II | McDaniel Life-Line LLC |
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.