Browse Drug Recalls
15 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 15 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 15 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 15, 2013 | Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution ... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution ... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amin... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution ... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solutio... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - di... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dial... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialys... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
| May 15, 2013 | Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino aci... | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... | Class II | Pentec Health |
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.