Browse Drug Recalls
1,152 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,152 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 1,152 FDA drug recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2021 | TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compound... | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 t... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... | Class II | Pfizer Inc. |
| Aug 13, 2021 | HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mounta... | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compound... | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfi... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... | Class II | Pfizer Inc. |
| Aug 13, 2021 | TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 13, 2021 | PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2021 | Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (... | Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, the... | Class II | ANHUI WELCOME FOREIGN TRADE CO.,LTD. |
| Aug 11, 2021 | Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x ... | Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine | Class I | Ebay Seller - John Nguyen |
| Aug 11, 2021 | Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India... | CGMP Deviations | Class II | Granules USA, Inc. |
| Aug 10, 2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Aug 10, 2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... | Non-Sterility: firm's third party lab confirmed microbial contamination. | Class I | SterRx, LLC |
| Aug 6, 2021 | Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For... | Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does ... | Class II | XELLIA PHARMACEUTICALS USA, LLC |
| Aug 6, 2021 | Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, Fo... | Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does ... | Class II | XELLIA PHARMACEUTICALS USA, LLC |
| Aug 6, 2021 | Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx onl... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Aug 5, 2021 | Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH... | Out of specification results for conductivity. | Class III | DuPont Nutrition USA, Inc |
| Aug 5, 2021 | Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx o... | Labeling: Not elsewhere classified: Mislabeling | Class III | Hikma Pharmaceuticals USA Inc. |
| Aug 3, 2021 | Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx O... | Superpotent Drug | Class I | Teligent Pharma, Inc. |
| Aug 3, 2021 | Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distribute... | Failed Impurities/Degradation Specifications | Class II | The Harvard Drug Group |
| Aug 2, 2021 | Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for:... | Presence of foreign matter | Class II | Macleods Pharma Usa Inc |
| Aug 2, 2021 | Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... | Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stabil... | Class II | Akorn, Inc. |
| Aug 2, 2021 | 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE IN... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Je Dois Lavoir LLC |
| Jul 30, 2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg ... | Failed Stability Specifications; out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Jul 30, 2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg ... | Failed Stability Specifications; out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Jul 30, 2021 | FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, R... | Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmen... | Class II | Custopharm, Inc. |
| Jul 30, 2021 | Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For ... | Lack of sterility assurance | Class II | BayCare Integrated Service Center, LLC /dba Bay... |
| Jul 29, 2021 | Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx onl... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceutic... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx on... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single us... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials,... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx on... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma,... | Defective container: possibility for lack of seal integrity. | Class II | Teligent Pharma, Inc. |
| Jul 29, 2021 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | Class II | PAI Holdings, LLC. dba Pharmaceutical Associate... |
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.