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Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

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DateProductReasonClassFirm
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.
Oct 3, 2016 PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-War... Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. Class II West-Ward Pharmaceutical
Oct 3, 2016 Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-War... Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolu... Class II West-Ward Pharmaceuticals Corp.
Sep 30, 2016 Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC... Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufac... Class III Amerisource Health Services
Sep 28, 2016 Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10... Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 28, 2016 Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10... Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 27, 2016 Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablet... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
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 27, 2016 Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, ... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
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 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 Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol table... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
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 Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
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 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 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 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 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 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 22, 2016 PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA
Sep 22, 2016 PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA
Sep 22, 2016 PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA
Sep 21, 2016 Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy N... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Co... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Com... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL v... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy,... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Well... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable K... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by W... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pha... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by We... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Co... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharma... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compou... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded ... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Trimix Injectable 30 mg/2 mg/40 mcg, 5 mL vial, Compounded by Wells Pharmacy,... Lack of Assurance of Sterility Class II Wells Pharmacy Network LLC
Sep 21, 2016 Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compo... 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.