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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Mar 22, 2018 Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL ambe... 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 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharm... 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 #3 (ALP10/PAPAV12/PHENT1), 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 HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Parte... 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/Anastrozole 120 mg/10 mg/4 mg pellet 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 Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Lipoic Acid 25mg/mL, 5 mL 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 Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial... 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 60 mg/4 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 Testosterone Cypionate 200mg/mL, 5 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 50 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 80 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 Progesterone 50 mg (SD) pellets in 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 Estradiol 50 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 Estradiol 55 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/Anastrozole 60 mg/1 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 Testosterone Propionate 100mg/mL, 5 mL 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 Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharm... 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 120 mg/8 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 TM #6 (ALP 25/PAPAV/PHENT1), 3 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 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 21, 2018 Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne... Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability... Class III Mayne Pharma Inc
Mar 19, 2018 Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0... Defective Container: This recall is being initiated due to product complaints regarding difficult... Class II Teva Pharmaceuticals USA
Mar 19, 2018 Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... Class III Glenmark Pharmaceuticals Inc., USA
Mar 19, 2018 Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Qual... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Lake Erie Medical & Surgical Supply Inc
Mar 15, 2018 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... Class I Bayer HealthCare Pharmaceuticals, 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.