Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 20, 2023 | Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Man... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 20, 2023 | Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distrib... | Failed Impurities/Degradation Specifications. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 20, 2023 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237... | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... | Class II | Omega & Delta Co., Inc. |
| Oct 20, 2023 | Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottle... | Failed Viscosity Specifications: Out-of-specification test results for viscosity | Class II | ITF PHARMA INC |
| Oct 20, 2023 | Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distribu... | Failed Impurities/Degradation Specifications. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx ... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dro... | CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. | Class II | Safecor Health, LLC |
| Oct 18, 2023 | Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Sc... | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... | Class II | Integrity Bio-Chemicals LLC |
| Oct 18, 2023 | Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla ... | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... | Class II | Integrity Bio-Chemicals LLC |
| Oct 18, 2023 | Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender ... | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... | Class II | Integrity Bio-Chemicals LLC |
| Oct 13, 2023 | Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distribute... | Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast S... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2023 | Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail sto... | CGMP Deviations: OTC products were stored outside of labeled temperature requirements. | Class II | Dollar Tree Distribution, Inc. |
| Oct 4, 2023 | Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ing... | CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and release... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 2, 2023 | Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, C... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL mult... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx o... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compo... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 6... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalm... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by ... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine ... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL s... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, R... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal adminis... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, C... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Co... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Sta... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Oct 2, 2023 | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Sep 29, 2023 | ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* ... | Microbial contamination of Non-Sterile Products | Class II | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Sep 29, 2023 | Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA | Microbial contamination of Non-Sterile Products | Class II | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Sep 28, 2023 | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pr... | Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product r... | Class II | Padagis US LLC |
| Sep 28, 2023 | Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL... | Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial.... | Class II | Eugia US LLC |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Cen... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syring... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syrin... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc.... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAP... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 6... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 21, 2023 | ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only,... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixtu... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL s... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAP... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services 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.