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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.