Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 25, 2018 | Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... | Labeling Not Elsewhere Classified: Misbranding. | Class III | Right Value Drug Stores, Inc. |
| Sep 25, 2018 | Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Sep 21, 2018 | Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only,... | Failed Disintegration Specifications: Out-of-specification disintegration test result obtained du... | Class II | Teva Pharmaceuticals USA |
| Sep 21, 2018 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, ... | Failed stability specifications - An out of specification result was observed for the test parame... | Class II | Dr. Reddy's Laboratories, Inc. |
| Sep 20, 2018 | Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Steril... | Lack of assurance of sterility: loss of container integrity. | Class II | Pfizer Inc. |
| Sep 20, 2018 | Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx ... | CGMP Deviations; rejected product was used to manufacture final bulk lot | Class II | Pfizer Inc. |
| Sep 20, 2018 | Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only... | Failed Stability Specifications: Out-of-specification test result for water content obtained duri... | Class II | Teva Pharmaceuticals USA |
| Sep 19, 2018 | Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: U... | Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified... | Class II | Upsher Smith Laboratories, Inc. |
| Sep 19, 2018 | Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: U... | Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified... | Class II | Upsher Smith Laboratories, Inc. |
| Sep 19, 2018 | Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, ... | Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. Th... | Class II | Pfizer Inc. |
| Sep 18, 2018 | Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 m... | Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging com... | Class III | Xiromed LLC |
| Sep 17, 2018 | treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for ... | Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel... | Class III | Otsuka Pharmaceutical Development & Commerciali... |
| Sep 17, 2018 | SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g t... | Microbial Contamination of Non-Sterile Product | Class II | Medline Industries Inc |
| Sep 17, 2018 | treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for... | Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel... | Class III | Otsuka Pharmaceutical Development & Commerciali... |
| Sep 17, 2018 | robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ... | Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly... | Class I | Endo Pharmaceuticals, Inc. |
| Sep 12, 2018 | Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bot... | Failed Impurities/Degradation Specifications: OOS for unknown impurities. | Class III | Dr. Reddy's Laboratories, Inc. |
| Sep 12, 2018 | Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd B... | Failed Impurities/Degradation Specifications: OOS for unknown impurities. | Class III | Dr. Reddy's Laboratories, Inc. |
| Sep 12, 2018 | Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for:... | Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-min... | Class III | Hetero Labs, Ltd. - Unit III |
| Sep 11, 2018 | Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx ... | Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at th... | Class II | Torrent Pharma Inc. |
| Sep 10, 2018 | Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL I... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- ND... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D S... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- ND... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, H... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 1... | Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes o... | Class II | Takeda Development Center Americas, Inc. |
| Sep 10, 2018 | Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 6... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Pow... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- ND... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- N... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas ---... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D S... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injec... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ----... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 696... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Te... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
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.