Browse Drug Recalls

1,680 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,680 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 1,680 FDA drug recalls — Class III.

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Date	Product	Reason	Class	Firm
Jan 29, 2018	Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (ND...	Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec...	Class III	Teva Pharmaceuticals USA
Jan 29, 2018	Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-...	Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec...	Class III	Teva Pharmaceuticals USA
Jan 29, 2018	Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (ND...	Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec...	Class III	Teva Pharmaceuticals USA
Jan 29, 2018	Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o...	Subpotent Drug: Out of specification for assay (stability testing)	Class III	Mckesson Packaging Services
Jan 29, 2018	Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx ...	Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De...	Class III	Dr. Reddy's Laboratories, Inc.
Jan 29, 2018	Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3...	Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec...	Class III	Teva Pharmaceuticals USA
Jan 24, 2018	Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use sy...	Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.	Class III	JCB Laboratories LLC
Jan 24, 2018	Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g...	Superpotent drug: failed assay throughout the stick after 6 months stability.	Class III	Oxygen Development Llc
Jan 22, 2018	Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manuf...	Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol	Class III	Ascent Pharmaceuticals, Inc.
Jan 22, 2018	Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by...	Defective container: presence of a hole in the liners of the caps covering the product bottle, in...	Class III	AbbVie Inc.
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.

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.