Browse Drug Recalls
2,151 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,151 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 2,151 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Dec 27, 2013 | Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz.,... | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... | Class II | Mangiacotti |
| Dec 27, 2013 | Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spr... | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... | Class II | Mangiacotti |
| Dec 27, 2013 | Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 m... | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... | Class II | Mangiacotti |
| Dec 27, 2013 | Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL ... | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... | Class II | Mangiacotti |
| Dec 12, 2013 | Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, ... | Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination fo... | Class I | Zions RX Formulations Services LLC dba RX Formu... |
| Nov 26, 2013 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli... | Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with ... | Class II | Humco Holding Group, Inc |
| Nov 22, 2013 | Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-... | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found... | Class II | Faria Limited LLC dba Sheffield Pharmaceuticals |
| Nov 22, 2013 | FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBU... | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found... | Class II | Faria Limited LLC dba Sheffield Pharmaceuticals |
| Nov 22, 2013 | Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBU... | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found... | Class II | Faria Limited LLC dba Sheffield Pharmaceuticals |
| Nov 16, 2013 | Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy... | Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Na... | Class II | Tower Pharmacy and Compounding |
| Oct 22, 2013 | Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured ... | Cross Contamination with Other Products: findings of carryover of trace amounts of a previously m... | Class II | Sandoz Incorporated |
| Oct 9, 2013 | Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufac... | Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended ... | Class II | Sandoz, Inc |
| Sep 24, 2013 | Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vani... | Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen ... | Class II | W.S. Badger Company Inc. |
| Sep 24, 2013 | Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Cal... | Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen ... | Class II | W.S. Badger Company Inc. |
| Sep 6, 2013 | Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL ... | Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro... | Class II | Triangle Compounding |
| Sep 6, 2013 | Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, ... | Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (fro... | Class II | Triangle Compounding |
| Aug 26, 2013 | Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Co... | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... | Class II | Leiter's Pharmacy |
| Aug 26, 2013 | Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose via... | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... | Class II | Leiter's Pharmacy |
| Aug 26, 2013 | Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vi... | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... | Class II | Leiter's Pharmacy |
| Aug 26, 2013 | Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Le... | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found af... | Class II | Leiter's Pharmacy |
| Aug 23, 2013 | Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Fre... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | JCB Labs LLC |
| Aug 23, 2013 | Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-2... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative C... | Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or po... | Class II | Creative Compounds |
| Aug 23, 2013 | Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Inje... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | JCB Labs LLC |
| Aug 23, 2013 | Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | JCB Labs LLC |
| Aug 23, 2013 | Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
| Aug 23, 2013 | Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 | The product lots are being recalled due to laboratory results indicating microbial contamination.... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELL... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
| Aug 23, 2013 | Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 3... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | JCB Labs LLC |
| Aug 23, 2013 | Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS ... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183 | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
| Aug 23, 2013 | Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMAC... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
| Aug 23, 2013 | NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... | Class II | Wellness Pharmacy, Inc. |
| Aug 23, 2013 | NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183 | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
| Aug 23, 2013 | Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 m... | Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... | Class II | Medaus, Inc. |
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.