Browse Drug Recalls

30 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 30 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 30 FDA drug recalls.

Clear
DateProductReasonClassFirm
May 15, 2014 Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Stree... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 2... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Stree... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street,... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th St... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Stre... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 2... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street,... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C S... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions

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.