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.

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DateProductReasonClassFirm
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.