Browse Drug Recalls
1,710 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,710 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 1,710 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 30, 2016 | Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa... | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on ... | Class III | Prinston Pharmaceutical Inc |
| May 28, 2016 | Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 ... | Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydro... | Class III | Par Pharmaceutical |
| 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 26, 2016 | Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz ... | Crystallization; Complaints that cream appears to have crystallized | Class III | Stratus Pharmaceuticals 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 | 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 | 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 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 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. |
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.