Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 9, 2018 | Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), pa... | Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its lab... | Class III | Alva-Amco Pharmacal Companies., Inc. |
| Mar 9, 2018 | Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by:... | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Class III | Akorn, Inc. |
| Mar 8, 2018 | Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr.... | Failed Stability Specifications:Out-of-specification results observed for viscosity during stabil... | Class III | Dr. Reddy's Laboratories, Inc. |
| Mar 5, 2018 | Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5... | Failed Impurities/Degradation Specifications | Class III | Novel Laboratories, Inc. |
| Mar 5, 2018 | Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... | Failed impurities/degradation specifications: Failure to water content and impurity | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 5, 2018 | Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... | Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... | Class III | Pine Pharmaceuticals, LLC |
| Mar 2, 2018 | Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flex... | Superpotent and Failed Stability Specifications; out of specification results for assay and water... | Class III | Renaissance Lakewood, LLC |
| Feb 28, 2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... | Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to ... | Class III | Osmotica Pharmaceutical Corp |
| Feb 23, 2018 | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured ... | Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polym... | Class III | AstraZeneca Pharmaceuticals LP |
| Feb 22, 2018 | labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Us... | Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indica... | Class III | SCA Pharmaceuticals, LLC. |
| Feb 21, 2018 | Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... | Failed Stability Specification: OOS low viscosity results discovered during retain testing. | Class III | Akorn, Inc. |
| Feb 14, 2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf... | Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. | Class III | LEADIANT BIOSCIENCES, INC |
| Feb 13, 2018 | Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufact... | Presence of Foreign Tablets/Capsules | Class III | Nostrum Laboratories Inc |
| Feb 7, 2018 | BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. ... | CGMP Deviations: not manufactured according to current good manufacturing practices. | Class III | Webrx dba RxPalace.com |
| Feb 5, 2018 | Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... | Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a fa... | Class III | Sun Pharmaceutical Industries, Inc. |
| Feb 5, 2018 | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... | Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... | Class III | Genentech, Inc. |
| Feb 5, 2018 | Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Isra... | Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily reca... | Class III | Teva Pharmaceuticals USA |
| Feb 2, 2018 | Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, M... | Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg | Class III | Aurobindo Pharma Ltd. |
| Feb 2, 2018 | NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... | Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... | Class III | ALLERGAN |
| 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, 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 | 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 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 | 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 | Atorvastatin Calcium Tablets 10 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 | Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Re... | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... | Class III | Dr. Reddy's Laboratories, Inc. |
| 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 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 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 54 mg, 100-count ... | Subpotent Drug | Class III | Osmotica Pharmaceutical Corp |
| Dec 18, 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 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, 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 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, 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. |
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.