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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Browse Drug Recalls

14,396 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,396 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 14,396 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Oct 16, 2015 Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downi... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen R... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 15, 2015 Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF ... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bo... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel c... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bo... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, B... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avob... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 5... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avob... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 15, 2015 Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL)... cGMP Deviations; product does not comply with cGMP requirements Class II Sesderma, SL
Oct 9, 2015 Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 2... Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due ... Class II Qualgen
Oct 9, 2015 Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH... Presence of foreign substance -This recall has been intiated due to the presence of a polyethylen... Class II Mutual Pharmaceutical Company, Inc.
Oct 9, 2015 Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg... Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due ... Class II Qualgen
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflow... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflow... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health M... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Ph... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manu... Presence of Particulate Matter. Class II Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Oct 7, 2015 Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pha... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflowe... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, B... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B &... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 6, 2015 TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 2... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Ph... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 2... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Sep 25, 2015 Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. Class II Actavis Laboratories, FL, Inc.
Sep 24, 2015 Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed b... Subpotent Drug Class II Pfizer Inc.
Sep 23, 2015 Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Inje... Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being com... Class II Diabetes Corporation of America dba DCA Pharmacy
Sep 22, 2015 P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, ... Lack of assurance of sterility Class II Bedford Pharmacy
Sep 22, 2015 Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedfo... Lack of assurance of sterility Class II Bedford Pharmacy
Sep 22, 2015 Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Rou... Lack of assurance of sterility Class II Bedford Pharmacy

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.