Browse Drug Recalls

1,702 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,702 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 1,702 FDA drug recalls, Class III.

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DateProductReasonClassFirm
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 18, 2016 Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles,... Failed Tablet/Capsule Specifications Class III Teva North America
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 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 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 16, 2016 VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, ... Defective delivery system: Softgel capsules are leaking. Class III Virtus Pharmaceuticals, Llc
May 13, 2016 PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class III Medaus, Inc.
May 13, 2016 Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottl... Chemical Contamination: Bottles may contain broken dessicants Class III Virtus Pharmaceuticals, Llc
May 5, 2016 Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by:... Discoloration: presence of scuffing marks on tablets. Class III KVK-Tech, Inc.
May 2, 2016 Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufa... Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obt... Class III Sandoz, Inc
May 2, 2016 Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufa... Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obt... Class III Sandoz, Inc
Apr 27, 2016 Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Ge... Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL ... Class III Genzyme Corporation / Genzyme Biosurgery
Apr 22, 2016 CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottl... Failed impurities/degradation specification: An out of specification results has been determined ... Class III Dr. Reddy's Laboratories, Inc.
Apr 22, 2016 Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bot... Labeling: Not elsewhere classified - count on the label was incorrect. Class III A-S Medication Solutions LLC.
Apr 12, 2016 SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC... Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. Class III Mckesson Packaging Services
Apr 8, 2016 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged ... Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 8, 2016 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged ... Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 8, 2016 BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged ... Failed Impurities/Degradation Specifications: high out of specification results for one of the kn... Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 7, 2016 Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi... Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of... Class III Fresenius Kabi USA, LLC
Apr 6, 2016 Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for:... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Apr 6, 2016 Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-51... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Apr 4, 2016 Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-c... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Mar 31, 2016 Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Bliste... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Amerisource Health Services
Mar 31, 2016 Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs ... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Amerisource Health Services
Mar 31, 2016 Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons,... Failed Dissolution Specifications Class III Purdue Pharma L.P.
Mar 31, 2016 ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professio... Subpotent Drug Class III Taro Pharmaceuticals U.S.A., Inc.
Mar 25, 2016 Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle... Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release ta... Class III Bryant Ranch Prepack Inc.
Mar 24, 2016 Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for Abb... Failed Content Uniformity Specifications Class III AbbVie Inc.
Mar 24, 2016 Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for:... Labeling: Incorrect or Missing Lot and/or Expiration Date Class III Lupin Limited
Mar 24, 2016 Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b)... Subpotent Drug Class III Biocon Inc
Mar 23, 2016 Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ... Failed pH Specifications: Confirmed high out of specification (OOS) results for pH. Class III Hospira Inc.
Mar 17, 2016 Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distribu... Labeling: Incorrect or Missing Lot and/or Exp. Date Class III Impax Laboratories, Inc.
Mar 17, 2016 Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distribu... Labeling: Incorrect or Missing Lot and/or Exp. Date Class III Impax Laboratories, Inc.
Mar 16, 2016 Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL... Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-sp... Class III Actavis Pharma Inc
Mar 15, 2016 Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL ... Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiratio... Class III Hospira Inc.
Mar 11, 2016 Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packag... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-coun... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by J... Labeling: Label Error on Declared Strength Class III Jubilant Draximage Inc
Mar 11, 2016 Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packag... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15... CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-coun... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Feb 29, 2016 col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-... Superpotent Drug: High out of specification results for assay at the 6 month time point interval. Class III Allegiant Health
Feb 25, 2016 Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per car... Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as... Class III Torrent Pharmaceuticals Limited
Feb 19, 2016 Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactur... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Limited
Feb 19, 2016 Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactu... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Limited
Feb 12, 2016 Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Do... Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with a... Class III Apace KY LLC
Feb 12, 2016 Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged i... Subpotent drug Class III Ecolab 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.