Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Sep 21, 2016 | Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by ... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Well... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells P... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded b... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compo... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells ... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharma... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounde... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pha... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells ... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compou... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 3... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial,... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Com... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectab... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Co... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells ... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, O... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Co... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL ... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by... | Lack of Assurance of Sterility | Class II | Wells Pharmacy Network LLC |
| Sep 21, 2016 | MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL via... | 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.