Browse Drug Recalls

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
Apr 3, 2018 Temozolomide 20 mg NDC 43975-0253-05 28 days supply Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 3, 2018 Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98 Lack of Processing Controls. Class II Kroger Specialty Pharmacy, Inc.
Apr 2, 2018 ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Apr 2, 2018 WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dis... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Mar 30, 2018 Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,... Failed Dissolution Specifications Class II AVKARE Inc.
Mar 30, 2018 PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 g... Microbial Contamination of Non-Sterile Products Class II Marcas Usa Llc
Mar 29, 2018 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-72... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC ... CGMP Deviations: the product was produced with substandard GMP manufacturing processes. Class II United Pacific Co Ltd
Mar 29, 2018 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 28, 2018 Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), El... cGMP Deviations Class II Elroselabs Inc.
Mar 28, 2018 Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc. cGMP Deviations Class II Elroselabs Inc.
Mar 28, 2018 Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, M... cGMP Deviations Class II Elroselabs Inc.
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL pack... Superpotent Drug Class II Lupin Pharmaceuticals Inc.
Mar 27, 2018 Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administratio... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 22, 2018 TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL a... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Ph... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Phar... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Spec... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialt... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specia... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL a... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 583... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Speci... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Special... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 58... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partel... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialt... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx onl... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialt... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Speci... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pha... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Special... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty 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.