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Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

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DateProductReasonClassFirm
May 26, 2016 Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Ka... Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc py... Class III Taro Pharmaceuticals U.S.A., Inc.
May 25, 2016 Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sa... Labeling: Incorrect or Missing Package Insert Class III Sandoz Inc
May 23, 2016 Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY T... Failed Dissolution Specifications Class II Nostrum Laboratories, Inc.
May 23, 2016 Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsul... Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were ... Class III Valeant Pharmaceuticals North America LLC
May 19, 2016 Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehring... Failed Impurities/Degradation Specification; 9 month stability Class III West-Ward Columbus Inc
May 19, 2016 Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Markete... Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. Class III Galderma Laboratories, L.P.
May 18, 2016 Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles,... Failed Tablet/Capsule Specifications Class III Teva North America
May 18, 2016 Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compoun... cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration Class III Attix Pharmaceuticals Inc
May 17, 2016 ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, We... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL ... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compoun... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... Class III Clinique International
May 17, 2016 TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy ... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Co... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL b... Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability Class II Akorn, Inc.
May 17, 2016 TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care C... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care C... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care C... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care C... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compound... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Phar... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... Class III Clinique International
May 17, 2016 MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL via... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Ph... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, W... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compoundin... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compound... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx on... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, R... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharm... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compou... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, W... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... Class III Clinique International
May 17, 2016 METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx ... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... Class III Clinique International
May 17, 2016 CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... Class III Clinique International
May 17, 2016 TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compoun... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, We... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care ... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compoundin... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy ... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding 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.