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 |
|---|---|---|---|---|
| Jun 23, 2017 | Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Com... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml B... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Dr... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Sl... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 22, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Jun 22, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Jun 22, 2017 | QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Jun 22, 2017 | Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Jun 21, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) ... | Lack of sterility assurance | Class II | SCA Pharmaceuticals |
| Jun 21, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq ... | Lack of sterility assurance | Class II | SCA Pharmaceuticals |
| Jun 21, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) ... | Lack of sterility assurance | Class II | SCA Pharmaceuticals |
| Jun 21, 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K... | Lack of sterility assurance | Class II | SCA Pharmaceuticals |
| Jun 19, 2017 | Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, ... | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blist... | Class II | Apace KY LLC |
| Jun 19, 2017 | Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose ... | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blist... | Class II | Apace KY LLC |
| Jun 19, 2017 | Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only.... | Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier | Class II | Fagron Compounding Services LLC dba Fagron Ster... |
| Jun 16, 2017 | Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Ma... | Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contai... | Class II | Time-Cap Laboratories, Inc. |
| Jun 16, 2017 | Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANT... | Lack of Assurance of Sterility | Class II | Alvogen, Inc |
| Jun 16, 2017 | Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANT... | Lack of Assurance of Sterility | Class II | Alvogen, Inc |
| Jun 16, 2017 | Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANT... | Lack of Assurance of Sterility | Class II | Alvogen, Inc |
| Jun 15, 2017 | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-d... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 gr... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 15, 2017 | Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. ... | Defective container: Oral solution leaking from container. | Class II | Tris Pharma Inc. |
| Jun 15, 2017 | Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose... | Lack of Sterility Assurance | Class II | Hospira a Pfizer Company |
| Jun 13, 2017 | CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.... | Microbial Contamination of Non Sterile Products; out of specification Total Plate Count | Class II | Sigan Industries Inc. |
| Jun 12, 2017 | Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. ... | Presence of foreign substance: glass particle | Class II | Vi-Jon, Inc. |
| Jun 9, 2017 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... | Class II | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... | Class II | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Steri... | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... | Class II | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... | Class II | Advanced Pharma Inc. |
| Jun 8, 2017 | TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 m... | GMP Deviations; FDA inspection found significant manufacturing practices that call into question ... | Class II | Phillips Co. |
| Jun 8, 2017 | StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3... | GMP Deviations; FDA inspection found significant manufacturing practices that call into question ... | Class II | Phillips Co. |
| Jun 8, 2017 | VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protec... | GMP Deviations; FDA inspection found significant manufacturing practices that call into question ... | Class II | Phillips Co. |
| Jun 8, 2017 | StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. ... | GMP Deviations; FDA inspection found significant manufacturing practices that call into question ... | Class II | Phillips Co. |
| Jun 8, 2017 | Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3... | GMP Deviations; FDA inspection found significant manufacturing practices that call into question ... | Class II | Phillips Co. |
| Jun 8, 2017 | Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 ... | GMP Deviations; FDA inspection found significant manufacturing practices that call into question ... | Class II | Phillips Co. |
| Jun 6, 2017 | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered s... | CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manu... | Class II | Bausch & Lomb, Inc. |
| Jun 5, 2017 | Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Mu... | Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of... | Class II | Apothecary By Design |
| Jun 1, 2017 | Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet pe... | Defective Container: Carton is missing the tablet blister strip and tablet. | Class II | L. Perrigo Company |
| Jun 1, 2017 | Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a... | Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsu... | Class II | Lucid Pharma LLC |
| Jun 1, 2017 | Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Dis... | CGMP Deviations | Class II | Xttrium Laboratories Inc |
| Jun 1, 2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged ... | Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import ... | Class II | American Pharmaceutical Ingredients LLC |
| Jun 1, 2017 | methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 ... | Lack of Assurance of Sterility | Class II | MedPark Pharmacy, LLC |
| May 26, 2017 | Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500... | CGMP Deviations: Lack of quality assurance at the API manufacturer. | Class II | American Pharmaceutical Ingredients LLC |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (... | Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an... | Class II | Global Marketing Enterprises, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 22, 2017 | Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription P... | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Class II | Dr. Reddy's Laboratories, Inc. |
| May 18, 2017 | ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total ... | Lack of assurance of sterility: Product bags leaking at seam. | Class II | SCA Pharmaceuticals |
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.