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
Jun 22, 2015 c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL R... Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used t... Class II Solutions Rx Pharmacy
Jun 18, 2015 Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for... Failed Dissolution Specifications: During routine stability testing at the 12 month time point, ... Class III Qualitest Pharmaceuticals
Jun 15, 2015 Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Lib... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Cent... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Li... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug C... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Dr... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Com... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial,... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Comp... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, L... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liber... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vial... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound C... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vi... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Cent... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Comp... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Co... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound ... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Com... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 12, 2015 PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrit... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a pres... Class I GC Natural Nutrition, Inc.
Jun 10, 2015 OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manuf... Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 ... Class II The Harvard Drug Group, LLC
Jun 10, 2015 Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Class II Vital Care Compounder
Jun 10, 2015 Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compo... Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Class II Vital Care Compounder
Jun 10, 2015 NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count b... Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an ... Class II AstraZeneca Pharmaceuticals LP
Jun 10, 2015 Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vit... Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Class II Vital Care Compounder
Jun 8, 2015 TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science ... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harrima... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life S... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harrima... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman... Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy Inc
Jun 8, 2015 BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Class II Life Science Pharmacy 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.