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.

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DateProductReasonClassFirm
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.