Browse Drug Recalls
1,720 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,720 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 1,720 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 19, 2018 | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638... | Discoloration: Product is supposed to be a white to off white homogenous cream and may have inter... | Class III | G & W Laboratories, Inc. |
| Jan 16, 2018 | Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius K... | Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related ... | Class III | Fresenius Kabi USA, LLC |
| Dec 22, 2017 | Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for... | Presence of foreign substance: metallic razor blade was found in one bottle. | Class III | Hetero Labs, Ltd. - Unit III |
| Dec 21, 2017 | Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Phar... | Failed Content Uniformity Specifications | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 18, 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count ... | Subpotent Drug | Class III | Osmotica Pharmaceutical Corp |
| Dec 18, 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count ... | Subpotent Drug | Class III | Osmotica Pharmaceutical Corp |
| Dec 15, 2017 | Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bo... | CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufact... | Class III | Akorn Inc |
| Dec 12, 2017 | Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufa... | Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing ... | Class III | Keryx Biopharmaceuticals, Inc. |
| Dec 5, 2017 | Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count ... | Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found p... | Class III | Sanofi-Aventis U.S. LLC |
| Nov 30, 2017 | Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Te... | Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil | Class III | BYL Solutions Inc. |
| Nov 28, 2017 | Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 1... | Failed Impurities/Degradation Specifications: high out of specification test results obtained for... | Class III | Teva Pharmaceuticals USA |
| Nov 21, 2017 | Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Ma... | Failed Dissolution Specification | Class III | Lupin Pharmaceuticals Inc. |
| Nov 13, 2017 | Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by:... | Failed Impurities/Degradation Specifications | Class III | Elite Laboratories Inc. |
| Nov 11, 2017 | Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 ... | Superpotent | Class III | Renaissance Lakewood, LLC |
| Nov 10, 2017 | Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spa... | Failed Stability Specifications | Class III | Bayer HealthCare Pharmaceuticals, Inc. |
| Nov 6, 2017 | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-... | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 6, 2017 | Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, ... | Superpotent | Class III | Claris Lifesciences Inc |
| Nov 6, 2017 | Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Via... | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 3, 2017 | bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, R... | Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntar... | Class III | Mylan Pharmaceuticals Inc. |
| Oct 30, 2017 | Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, me... | Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 30, 2017 | Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only,... | Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Oct 19, 2017 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... | Failed Impurities/Degradation Specifications. | Class III | Allergan Sales, LLC |
| Oct 19, 2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, All... | Failed Impurities/Degradation Specifications. | Class III | Allergan Sales, LLC |
| Oct 17, 2017 | Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only,... | Failed Dissolution Specifications: Low out of specification results for dissolution. | Class III | Teva Pharmaceuticals USA |
| Oct 13, 2017 | Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: T... | Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the i... | Class III | Sanofi-Aventis U.S. LLC |
| Oct 12, 2017 | Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, R... | Labeling: Incorrect or Missing Package Insert. | Class III | Genzyme Corporation |
| Oct 3, 2017 | Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CV... | Failed impurities/degradation specifications: Famotodine has an out of specification result for a... | Class III | Dr. Reddy's Laboratories, Inc. |
| Sep 26, 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg p... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 25, 2017 | Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 6809... | Subpotent Drug: low out of specification results. | Class III | Precision Dose Inc. |
| Sep 25, 2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-c... | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... | Class III | Amneal Pharmaceuticals, Inc. |
| Sep 25, 2017 | Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78... | Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap ... | Class III | Sandoz Inc |
| Sep 25, 2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100... | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... | Class III | Amneal Pharmaceuticals, Inc. |
| Sep 22, 2017 | Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist.... | Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incor... | Class III | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Sep 20, 2017 | Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceutical... | Cross contamination with other products: traces of Dapsone were found in the finished product. | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Sep 13, 2017 | Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in... | Failed Impurities/Degradation Specifications. | Class III | Vi-Jon, Inc. |
| Sep 13, 2017 | Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distribute... | Failed Stability Specifications | Class III | Vi-Jon, Inc. |
| Sep 13, 2017 | Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Vi-Jon, Inc. |
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Pa... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Sep 8, 2017 | AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testo... | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Class III | AbbVie Inc. |
| Sep 5, 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... | Failed Impurities/Degradation Specification; out-of-specification results for individual unknown ... | Class III | Aidarex Pharmaceuticals LLC |
| Sep 5, 2017 | ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhard... | Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lo... | Class III | Aidarex Pharmaceuticals LLC |
| Aug 29, 2017 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packag... | Failed Stability Specifications | Class III | Amerisource Health Services |
| Aug 28, 2017 | Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose card... | Failed moisture limits: Out of specification for moisture content. | Class III | Mckesson Packaging Services |
| Aug 22, 2017 | Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufacture... | Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specificatio... | Class III | Wockhardt Usa Inc. |
| Aug 17, 2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 m... | Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substa... | Class III | VistaPharm, Inc. |
| Aug 11, 2017 | Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-cou... | Failed Impurities/Degradation Specifications:Out of specification results for individual unknown ... | Class III | PD-Rx Pharmaceuticals, Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750m... | Failed Dissolution Specifications | Class III | Pfizer Inc. |
| Aug 4, 2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 ... | Failed Dissolution Specifications | Class III | Pfizer 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.