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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

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DateProductReasonClassFirm
Nov 10, 2015 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 14... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 9, 2015 Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 o... Presence of Foreign Substance Class II Freedom Pharmaceuticals Inc
Nov 6, 2015 Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol... Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecal... Class I Glades Drugs Inc.
Nov 4, 2015 Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe f... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal inje... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... Class III Dr. Reddy's Laboratories, Inc.
Nov 4, 2015 Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... Class III Dr. Reddy's Laboratories, Inc.
Nov 4, 2015 Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Re... Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of... Class III Dr. Reddy's Laboratories, Inc.
Nov 4, 2015 Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 2, 2015 Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tabl... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Oct 30, 2015 Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor ... Failed Impurities/Degradation Specifications: Out of specifications results for impurities. Class III Avantor Performance Materials Inc
Oct 29, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton,... Presence of Particulate Matter Class II Amerisource Health Services
Oct 29, 2015 EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx onl... Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP mono... Class III PQ Corporation
Oct 28, 2015 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled au... Defective Delivery System; potential to have inaccurate dosage delivery Class I Sanofi-Aventis U.S. LLC
Oct 28, 2015 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled aut... Defective Delivery System; potential to have inaccurate dosage delivery Class I Sanofi-Aventis U.S. LLC
Oct 27, 2015 Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topic... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ... Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of... Class II Steris Corp
Oct 27, 2015 Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-3... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) ,... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx ... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 26, 2015 Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct ... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Par Pharmaceutical Inc.
Oct 26, 2015 Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bot... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Par Pharmaceutical Inc.
Oct 21, 2015 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 m... Failed Stability Specifications: Out of Specification results obtained for preservative butylpara... Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Oct 21, 2015 Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, ... Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was foun... Class III Breckenridge Pharmaceutical, Inc
Oct 20, 2015 Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bott... Labeling: Incorrect or Missing Lot AND/OR Exp Date. Class III Teva Pharmaceutical Industries
Oct 19, 2015 T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Testosterone CYP Inj 200 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Spr... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street, S... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Testost CYP 200mg/mL SUS, Rx, Western Drug Inc. 106 E. Main Street, Springerv... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Spri... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springervil... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Sprin... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizon... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 19, 2015 VitB12/VitC/VitB3/VitB9 Inj, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Stre... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Spri... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc.... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Novarel "HCG" 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springer... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 10... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 HCG 1000unit/10mL MTU vial, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Sprin... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springervil... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Sp... Lack of Assurance of Sterility Class II Western Drug

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.