Browse Drug Recalls
2,138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,138 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 2,138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 6, 2014 | Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white spr... | Microbial Contamination of Non-Sterile Product | Class II | HLI dba Humphreyline Inc |
| Jul 24, 2014 | Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescr... | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence... | Class II | Fagron, Inc |
| Jul 24, 2014 | Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For pr... | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence... | Class II | Fagron, Inc |
| Jul 24, 2014 | Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescri... | Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence... | Class II | Fagron, Inc |
| Jun 25, 2014 | Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Ph... | Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold co... | Class I | Pharmacy Creations |
| May 28, 2014 | del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Ph... | Non Sterility; microbial contamination identified as Aspergillus species | Class I | Central Admixture Pharmacy Services, Inc. |
| May 28, 2014 | adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pha... | Non Sterility; microbial contamination identified as Aspergillus species | Class I | Central Admixture Pharmacy Services, Inc. |
| May 28, 2014 | PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services,... | Non Sterility; microbial contamination identified as Aspergillus species | Class I | Central Admixture Pharmacy Services, Inc. |
| May 28, 2014 | LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Servic... | Non Sterility; microbial contamination identified as Aspergillus species | Class I | Central Admixture Pharmacy Services, Inc. |
| Apr 28, 2014 | TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bott... | Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone ... | Class II | Ferring Pharmaceuticals Inc |
| Apr 22, 2014 | Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 4279... | Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are ... | Class II | SigmaPharm Laboratories LLC |
| Apr 14, 2014 | phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufact... | Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside... | Class II | Fresenius Medical Care Holdings, Inc. |
| Mar 24, 2014 | Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Ma... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 3, 2014 | Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC On... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC ... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Mad... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC ... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. ... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OT... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made ... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Ma... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Med... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC O... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicin... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OT... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC ... | Penicillin Cross Contamination. | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Coug... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC ... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Ma... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, O... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine,... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid ... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Mar 3, 2014 | Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. ... | Penicillin Cross Contamination | Class II | Terra-Medica Inc. |
| Feb 14, 2014 | Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: W... | Chemical Contamination: The recalling firm received notice that their supplier is recalling capsu... | Class II | Legacy Pharmaceutical Packaging |
| Feb 12, 2014 | Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-6... | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. | Class II | Teva Pharmaceuticals USA |
| Feb 12, 2014 | Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in P... | Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. | Class II | Teva Pharmaceuticals USA |
| Feb 11, 2014 | Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactur... | Cross Contamination with Other Products: Product contains Promacta (eltrombopag). | Class III | Viiv Healthcare Company |
| Jan 3, 2014 | a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 1... | Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count... | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 27, 2013 | Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 ... | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... | Class II | Mangiacotti |
| Dec 27, 2013 | Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 ... | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... | Class II | Mangiacotti |
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.