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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2016 | Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 14, 2016 | Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60... | Failed Stability Specifications; out-of specification value for homogeneity / phase separation. | Class II | Akorn Inc |
| Nov 13, 2016 | Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, M... | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence ... | Class I | Ultimate Body Tox |
| Nov 9, 2016 | L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| Nov 9, 2016 | Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01),... | Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence o... | Class II | VistaPharm, Inc. |
| Nov 9, 2016 | L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Packag... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| Nov 8, 2016 | Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.... | Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and ... | Class III | Care-Tech Laboratories, Inc. |
| Nov 7, 2016 | LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, R... | Superpotent | Class II | Pfizer Inc. |
| Nov 4, 2016 | Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted)... | Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the stren... | Class III | West-Ward Pharmaceuticals Corp. |
| Nov 3, 2016 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 03... | Failed Impurities/Degradation Specifications: OOS results for known compound. | Class III | Mylan Pharmaceuticals Inc. |
| Nov 2, 2016 | Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactu... | Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of... | Class II | Ascend Laboratories LLC |
| Nov 2, 2016 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/... | Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental... | Class II | Fallon Wellness Pharmacy, L.L.C. |
| Nov 2, 2016 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL ... | Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental... | Class II | Fallon Wellness Pharmacy, L.L.C. |
| Nov 2, 2016 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 3... | Failed Dissolution Specifications; 6 month time point | Class III | Zydus Pharmaceuticals USA Inc |
| Nov 1, 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, ... | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... | Class III | Teva Pharmaceuticals USA |
| Nov 1, 2016 | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/m... | Lack of Assurance of Sterility: Complaints of broken tips on the ampules. | Class II | Hospira Inc. |
| Nov 1, 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, ... | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... | Class III | Teva Pharmaceuticals USA |
| Oct 28, 2016 | Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-7... | CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... | Class II | Nationwide Laboratories, LLC |
| Oct 28, 2016 | Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-7... | CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... | Class II | Nationwide Laboratories, LLC |
| Oct 28, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... | CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... | Class II | Nationwide Laboratories, LLC |
| Oct 28, 2016 | KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP,... | Failed Stability Specifications: Low Out of Specification results for alcohol content. | Class III | Sun Pharmaceutical Industries, Inc. |
| Oct 28, 2016 | Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle | Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (... | Class I | Love My Tru Body |
| Oct 28, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... | CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... | Class II | Nationwide Laboratories, LLC |
| Oct 27, 2016 | Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-co... | Failed Dissolution Specifications: The firm was notified that there was a dissolution out of spec... | Class III | Amerisource Health Services |
| Oct 24, 2016 | UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: M... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration con... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 11... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 1... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 21, 2016 | Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akor... | Subpotent Drug: concentration of product is less than labeled amount. | Class II | Akorn Inc |
| Oct 20, 2016 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx ... | Labeling: Label error on declared strength. Package Insert -Error in the Description section of t... | Class III | CutisPharma, Inc. |
| Oct 20, 2016 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx on... | Labeling: Label error on declared strength. Package Insert -Error in the Description section of t... | Class III | CutisPharma, Inc. |
| Oct 19, 2016 | Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-coun... | Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be a... | Class III | Janssen Ortho L.L.C. |
| Oct 19, 2016 | Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Man... | Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial ... | Class II | Inventia Healthcare Private Limited |
| Oct 19, 2016 | Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM ... | Labeling: Missing Label | Class III | Sandoz Inc |
| Oct 18, 2016 | HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepare... | Subpotent Drug: due to failed potency results of 74% (spec. 80-125%). | Class III | Town and Country Compounding and Consultation S... |
| Oct 18, 2016 | Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 O... | Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of... | Class III | GSK Consumer Healthcare |
| Oct 13, 2016 | Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd:... | Failed impurities/degradation specifications: due to out-of-specification result for the Related ... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 13, 2016 | AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Indi... | Presence of Foreign Tablets/Capsules | Class III | Amerisource Health Services |
| Oct 12, 2016 | Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only,... | Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly... | Class III | Pharm D Solutions, LLC |
| Oct 12, 2016 | Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx onl... | Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the fir... | Class II | Pharmedium Services, LLC |
| Oct 12, 2016 | HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection... | Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units inste... | Class III | Pharm D Solutions, LLC |
| Oct 6, 2016 | DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane ... | Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Oct 6, 2016 | NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and d... | Presence of Foreign Tablets/Capsules | Class III | Actavis Elizabeth LLC |
| Oct 6, 2016 | Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dis... | Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 1... | Class II | Boehringer Ingelheim 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.