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 12, 2019 | S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red ... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mo... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glas... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Moun... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml gla... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass via... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass v... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irriga... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-LYSINE HCL 100MG/ML MDV, 30ML vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain ... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b)... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml ... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compound... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S071720... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Onl... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml,... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mo... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PRO... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) ... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compou... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Co... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 1... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 9, 2019 | Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 698... | Superpotent Drug: products were found to be contaminated and above specification for lidocaine as... | Class II | Ridge Properties, LLC |
| Aug 9, 2019 | Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-07... | Superpotent Drug: products were found to be contaminated and above specification for lidocaine as... | Class II | Ridge Properties, LLC |
| Aug 9, 2019 | Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister c... | Failed Dissolution Specifications | Class II | American Health Packaging |
| Aug 9, 2019 | Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 6... | Superpotent Drug: products were found to be contaminated and above specification for lidocaine as... | Class II | Ridge Properties, LLC |
| Aug 9, 2019 | PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, pac... | Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above... | Class II | Ridge Properties, LLC |
| Aug 9, 2019 | Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (... | Superpotent Drug: products were found to be contaminated and above specification for lidocaine as... | Class II | Ridge Properties, LLC |
| Aug 9, 2019 | PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged... | Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above... | Class II | Ridge Properties, LLC |
| Aug 8, 2019 | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed... | Class II | Alkermes Inc |
| Aug 5, 2019 | Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lu... | Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product c... | Class II | RemedyRepack Inc. |
| Jul 29, 2019 | Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured fo... | Failed Dissolution Specifications | Class II | Upsher Smith Laboratories, Inc. |
| Jul 26, 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) ... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) ... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 7... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochlorid... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each displa... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eye... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 eac... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each displa... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (ca... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, 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.