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 |
|---|---|---|---|---|
| Aug 20, 2021 | Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Ho... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Hom... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills , Packaged in (a) 2 dr, ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Ma... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers A... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Cistus Canadensis 5X Coldness* 20% Alcohol drops, Packaged in a) 15ml; b) 50 ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Viola od 6X, 30X, Bee Stings*, Sucrose/Lactose Pills, 6X Packaged in a) 4 Dr... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medici... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argen... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 19, 2021 | Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Mark... | Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/2... | Class II | Rhodes Pharmaceuticals, L.P. |
| Aug 19, 2021 | Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only,... | Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL act... | Class II | Eli Lilly & Company |
| Aug 18, 2021 | Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Green... | Lack of Assurance of Sterility | Class II | Prescription Labs Inc dba Greenpark |
| Aug 17, 2021 | Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pen... | A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product w... | Class II | RemedyRepack Inc. |
| Aug 13, 2021 | TEST CYP 25MG/ML IN ETHYL OLEATE 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 | VIT B COMPLEX INJ SOLN (HP), 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 | BENZALKONIUM CHLORIDE 0.013% SOLUTION, 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 | Calcium Chloride, 100 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 5000MCG/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 | 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 | ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH 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 | CALCIUM GLUCONATE 10% INJ (PF), 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 | MIC 25/50/50MG/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 | Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... | Class II | Pfizer Inc. |
| Aug 13, 2021 | ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compoundin... | 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 | VIT B COMPLEX INJ SOLN (HP), 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 12.5MG/ML MDV 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 | PROGESTERONE 100MG/ML MDV OIL INJECTION, 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 | LEVOCARNITINE 100MG/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 | Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfiz... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... | Class II | Pfizer Inc. |
| Aug 13, 2021 | MIC/B12A/B6 15/50/100 5MG/50MG/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 | Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 m... | Failed impurities/degradation specification: Out of Specification for an unknown impurity observe... | Class II | Akorn, Inc. |
| Aug 13, 2021 | ACETYLCYSTEINE 2% OPTH 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 | Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by:... | Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle | Class II | Zydus Pharmaceuticals (USA) Inc |
| Aug 13, 2021 | LEVOCARNITINE 100MG/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 | MIC/B12A 25/50/50MG/ML 1MG/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 13, 2021 | Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laborator... | Failed Impurities Specifications: Out of Specification impurity results obtained during routine t... | Class II | SigmaPharm Laboratories LLC |
| Aug 13, 2021 | FOLIC ACID 10MG/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 | 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 | 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 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... |
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.