Browse Drug Recalls
14,396 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,396 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 14,396 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 10, 2015 | Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL,... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounde... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, R... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148,... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | 0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx On... | Lack of Assurance of Sterility | Class II | Walgreens Infusion Services |
| Nov 10, 2015 | 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option... | 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 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 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 | 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 | 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 |
| 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 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 | 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 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 | 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 | 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 19, 2015 | Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Stree... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springe... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springervi... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springervi... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Spr... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug ... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerv... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Stree... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, S... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Stre... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springervill... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Spring... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 10... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springe... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springe... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, ... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, ... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springer... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springe... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springe... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Sodium Chloride 0.9% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerv... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Spring... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, ... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Spr... | Lack of Assurance of Sterility | Class II | Western Drug |
| Oct 19, 2015 | Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville... | 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.