Browse Drug Recalls

6,250 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,250 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 6,250 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Nov 17, 2016	MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/M...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Com...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/m...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-C...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). C...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compo...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 m...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 ...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 17, 2016	Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Cholin...	Lack of Assurance of Sterility	Class II	Tri-Coast Pharmacy
Nov 9, 2016	L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Packag...	Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns...	Class II	Sandoz Inc
Nov 9, 2016	L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single...	Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns...	Class II	Sandoz Inc
Nov 2, 2016	PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL ...	Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental...	Class II	Fallon Wellness Pharmacy, L.L.C.
Nov 2, 2016	PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/...	Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental...	Class II	Fallon Wellness Pharmacy, L.L.C.
Nov 1, 2016	Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/m...	Lack of Assurance of Sterility: Complaints of broken tips on the ampules.	Class II	Hospira Inc.
Oct 12, 2016	Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx onl...	Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the fir...	Class II	Pharmedium Services, LLC
Oct 5, 2016	Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx...	Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the ...	Class II	Par Pharmaceutical, Inc.
Sep 27, 2016	Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744...	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 27, 2016	Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 27, 2016	Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North America...	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 27, 2016	USCG Boat Response Kit - Product Code 80-0353, North American Rescue	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 27, 2016	Aid Backpack Kit - Product Code 85-0917, North American Rescue	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 27, 2016	Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 27, 2016	K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-03...	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 27, 2016	Range Trauma Kit - Product Code 85-1274, North American Rescue	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 27, 2016	Amphibious Trauma Kit - Product Code 85-0639, North American Rescue	Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wa...	Class II	North American Rescue LLC.
Sep 23, 2016	Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-f...	Non-Sterility: failed sterility test result.	Class I	Guardian Pharmacy Services
Sep 21, 2016	Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by ...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 ...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pha...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compo...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injecta...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounde...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded b...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wel...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 ...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network LLC
Sep 21, 2016	Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wel...	Lack of Assurance of Sterility	Class II	Wells Pharmacy Network 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.