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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

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DateProductReasonClassFirm
Oct 16, 2015 L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwe... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, D... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McE... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Su... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001... Lack of Assurance of Sterility Class II Downing Labs, LLC
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 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 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 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 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 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 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 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 13, 2015 Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine H... Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as a... Class III Rx PAK
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 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 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 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 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 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/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 (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/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 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 (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 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 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 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 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 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 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 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 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 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

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.