Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 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 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 | 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 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 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 |
| Feb 8, 2019 | Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL sin... | 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 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 6, 2019 | Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) b... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, E... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 f... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of... | Labeling: Incorrect expiration date. | Class II | Advanced Pharma Inc. |
| Feb 4, 2019 | Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl... | Failed Stability Specification: out of specification results for Sodium Perborate | Class II | Akorn Inc |
| Feb 4, 2019 | 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hos... | CGMP Deviations | Class II | ICU Medical Inc |
| Feb 1, 2019 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... | Defective Container: Potential for broken glass in the neck area of the glass bottles. | Class II | Mylan Pharmaceuticals Inc. |
| Jan 31, 2019 | Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx ... | Failed Dissolution Specifications: Out of specification results observed for high dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| Jan 29, 2019 | Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compoun... | Lack of assurance of sterility. | Class II | US Compounding Inc |
| Jan 24, 2019 | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date an... | Class II | US Compounding Inc |
| Jan 24, 2019 | BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distr... | Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. | Class II | Sun Pharmaceutical Industries, 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.