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.

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DateProductReasonClassFirm
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.