Source
FDA Recalls
The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.
68,659Total Recalls
www.fda.gov →Official Site
Have an unsafe medication, device, or food to report?
Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.
How to report to FDA →68,659 recalls
High RiskFDA
American Pharmaceutical Ingredients Llc
Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highl...
Drugs0 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (ND...
Supplements0 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7);...
Drugs12,300 affectedFeb 9, 2018
High RiskFDA
Apace Ky Llc
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufac...
Oral Drugs630 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Ro...
Drugs10,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8...
Drugs240 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597...
Drugs116,850 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road...
Drugs73 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014...
Drugs606,950 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed b...
Drugs75 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients,...
Drugs12,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by A...
Drugs29,550 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075...
Drugs193,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8...
Drugs12,725 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC ...
Drugs7,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (N...
Drugs10,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), R...
Drugs10,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, ...
Drugs10,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packe...
Drugs1,300 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 5...
Drugs33,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC ...
Drugs47,500 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4)...
Drugs5,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-...
Drugs22,900 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g...
Drugs26,500 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7)...
Drugs74,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by Americ...
Drugs25,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-...
Drugs13,335 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7...
Drugs48,525 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8...
Drugs166,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 5...
Drugs192,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 5...
Drugs15,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (N...
Drugs3,675 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) ...
Drugs1,638 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c...
Drugs0 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4),...
Drugs684 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC...
Drugs225,300 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, pac...
Drugs8,300 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25...
Drugs1,050,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-...
Drugs106,200 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-...
Drugs200,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (ND...
Drugs52,000 affectedFeb 9, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, ...
Drugs5,800 affectedFeb 9, 2018
CriticalFDA
Weis Markets
Weis Sunbury, PA 17801; Penne W/Asiago Sauce And Grilled Chix Small Meal; multiple weight. SCALE UPC - 205377-00000
Food110 affectedFeb 8, 2018
High RiskFDA
Vitalab Co Inc
Product packaged in the following ways A) Sonne's, No. 17, Natural Source Vitamin C, Dietary Supplement, (920 mg tablet wt.) Contents - 1...
Supplements1,703 affectedFeb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems...
Medical Devices119 affectedFeb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Surgical Devices876 affectedFeb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Surgical Devices3,196 affectedFeb 8, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
Surgical Devices383 affectedFeb 8, 2018