Browse Drug Recalls
119 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 119 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 119 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2013 | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx... | Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to... | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass conta... | Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and ... | Class I | Baxter Healthcare Corp. |
| Nov 12, 2013 | 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for ... | Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be... | Class II | Baxter Healthcare Corp. |
| Jul 24, 2013 | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... | Defective Container: There is a potential for frangible components to be broken, resulting in a l... | Class II | Baxter Healthcare Corp. |
| May 21, 2013 | Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 20... | Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... | Class II | Baxter Healthcare Corp. |
| May 21, 2013 | 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (ND... | Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... | Class II | Baxter Healthcare Corp. |
| May 21, 2013 | Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Bax... | Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... | Class II | Baxter Healthcare Corp. |
| May 21, 2013 | 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only,... | Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... | Class II | Baxter Healthcare Corp. |
| May 21, 2013 | Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plast... | Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for po... | Class II | Baxter Healthcare Corp. |
| May 21, 2013 | Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Cont... | Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... | Class II | Baxter Healthcare Corp. |
| Feb 27, 2013 | 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, ... | Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injec... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, pr... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVI... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product cod... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, produ... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
| Sep 21, 2012 | 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Ba... | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... | Class II | Baxter Healthcare Corp. |
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.