Browse Drug Recalls
1,141 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,141 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 1,141 FDA drug recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 4, 2017 | Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subc... | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product ... | Class II | Amgen, Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 ... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750m... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Aug 4, 2017 | Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Ma... | Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% ... | Class II | Degasa Sa De Cv |
| Aug 3, 2017 | Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured... | Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. | Class I | Amneal Pharmaceuticals of New York, LLC |
| Aug 3, 2017 | Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g)... | Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jel... | Class II | MEDLINE INDUSTRIES INC |
| Aug 3, 2017 | Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10... | Failed Impurities/Degradation Specifications: out-of-specification results obtained for individua... | Class III | KVK-Tech, Inc. |
| Aug 2, 2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl o... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (23... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, On... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One... | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Aug 2, 2017 | Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 3... | Failed Moisture Limits: out of specification test results for water content obtained during stabi... | Class III | Teva Pharmaceuticals USA |
| Aug 1, 2017 | NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count p... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared silde... | Class I | The Ampt Life, LLC |
| Jul 28, 2017 | Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals In... | Failed Tablet/Capsule Specification: out of specification for tablet weight. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jul 26, 2017 | Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Singl... | Presence of Particulate Matter: Silicone oil | Class II | HOSPIRA INC, LAKE FOREST |
| Jul 26, 2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... | Presence of Particulate Matter: Silicone oil | Class II | HOSPIRA INC, LAKE FOREST |
| Jul 26, 2017 | 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container... | Presence of Particulate Matter; stainless steel | Class II | ICU Medical Inc |
| Jul 26, 2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... | Presence of Particulate Matter: Silicone oil | Class II | HOSPIRA INC, LAKE FOREST |
| Jul 25, 2017 | Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 po... | Failed Impurities/Degradation Specifications: high out of specification results for related compo... | Class III | Teva Pharmaceuticals USA |
| Jul 24, 2017 | Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For:... | Failed Tablet/Capsule Specification; out of specification for tablet weight | Class II | Teva Pharmaceuticals USA |
| Jul 24, 2017 | LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by La... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: product... | Class I | EZWeightLossTX LLC |
| Jul 24, 2017 | LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by L... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: product... | Class I | EZWeightLossTX LLC |
| Jul 21, 2017 | Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in ... | Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil a... | Class I | Chiavna Saffron LLC |
| Jul 20, 2017 | Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for... | Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/... | Class II | Hetero USA Inc |
| Jul 19, 2017 | Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Ma... | Failed impurities/degradation specifications: Out of specification for a related compound C. | Class III | AVKARE Inc. |
| Jul 17, 2017 | Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net W... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methox... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red pac... | Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclar... | Class I | BESTHERBS COFFEE LLC |
| Jul 17, 2017 | Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Ne... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxyci... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bott... | Microbial contamination of non-sterile products: product was found to contain mold, identified as... | Class II | Vi-Jon, Inc. |
| Jul 14, 2017 | Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single... | Lack of Sterility Assurance. | Class II | Cantrell Drug Company |
| Jul 14, 2017 | Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg ... | Lack of Sterility Assurance. | Class II | Cantrell Drug Company |
| Jul 14, 2017 | Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantre... | Lack of Sterility Assurance. | Class II | Cantrell Drug Company |
| Jul 14, 2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 m... | Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceut... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only,... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmac... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
| Jul 14, 2017 | PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmace... | Lack of Assurance of Sterility; product has the potential to leak. | Class II | SCA Pharmaceuticals |
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.