Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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DateProductReasonClassFirm
Dec 27, 2013 Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL ... Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... Class II Mangiacotti
Dec 27, 2013 Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 m... Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... Class II Mangiacotti
Dec 27, 2013 Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spr... Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... Class II Mangiacotti
Dec 27, 2013 Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz.,... Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... Class II Mangiacotti
Dec 27, 2013 Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 ... Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... Class II Mangiacotti
Dec 27, 2013 Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 ... Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia... Class II Mangiacotti
Dec 23, 2013 Burn 7 Capsules, supplied in 30 capsules bottle Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 diet... Class I Deseo Rebajar
Dec 23, 2013 Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose... Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass co... Class I Hospira Inc.
Dec 23, 2013 Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactur... Presence of Foreign Substance; metal particulates were visually observed in the tablets. Class II Watson Laboratories Inc
Dec 20, 2013 CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povido... Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nai... Class II Carefusion 2200 Inc
Dec 20, 2013 CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povid... Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nai... Class II Carefusion 2200 Inc
Dec 20, 2013 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. Class II Watson Laboratories, Inc.-(Actavis) - Florida
Dec 19, 2013 All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc.... Lack of Assurance of Sterility Class II Abrams Royal Pharamacy
Dec 19, 2013 MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis Class I Abrams Royal Pharamacy
Dec 18, 2013 Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Man... Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of sp... Class II Teva Pharmaceuticals USA
Dec 18, 2013 Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured... Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of sp... Class II Teva Pharmaceuticals USA
Dec 16, 2013 VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx On... Failed Stability Testing: This product is below specification for preservative content. Class III Bracco Diagnostics Inc
Dec 16, 2013 Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) ... Failed impurities/degradation specifications; out of specification for the known impurity 4-chlor... Class III Qualitest Pharmaceuticals
Dec 13, 2013 Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufac... Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP... Class II Corepharma LLC
Dec 13, 2013 Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tabl... Failed Dissolution Specification; 12-Month stability interval. Class II Dr. Reddy's Laboratories, Inc.
Dec 12, 2013 Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Disp... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, ... Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination fo... Class I Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For ... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, Fo... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Ad... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified ... Class II Hospira Inc.
Dec 11, 2013 HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only.... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, Inc.
Dec 11, 2013 HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only.... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, Inc.
Dec 11, 2013 HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TEC... Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from... Class II KVK-Tech, Inc.
Dec 10, 2013 Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe... Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutram... Class I Slim Beauty USA
Dec 10, 2013 Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Dome... Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphth... Class I Slim Beauty USA
Dec 10, 2013 Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscor... Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphth... Class I Slim Beauty USA
Dec 9, 2013 Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (ND... Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial... Class II Actavis Inc
Dec 6, 2013 FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Do... Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point Class III Fresenius Kabi USA, LLC
Dec 4, 2013 Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 mete... Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aer... Class III Teva Pharmaceuticals USA
Nov 27, 2013 Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle,... Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit ... Class II Wockhardt Usa Inc.
Nov 27, 2013 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Bra... Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 ... Class II B. Braun Medical Inc
Nov 26, 2013 Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva ... Failed Tablet/Capsule Specifications: There is a potential for broken tablets. Class II Teva Pharmaceuticals USA
Nov 26, 2013 Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli... Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with ... Class II Humco Holding Group, Inc
Nov 22, 2013 Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBU... Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found... Class II Faria Limited LLC dba Sheffield Pharmaceuticals
Nov 22, 2013 Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun C... Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of t... Class II Physicians Total Care, Inc.
Nov 22, 2013 FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBU... Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found... Class II Faria Limited LLC dba Sheffield Pharmaceuticals
Nov 22, 2013 Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-... Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found... Class II Faria Limited LLC dba Sheffield Pharmaceuticals
Nov 21, 2013 Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Conta... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, C... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical Inc
Nov 21, 2013 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy ... Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... Class I B. Braun Medical 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.