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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 16, 2018 | SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per fil... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, Inc. |
| Nov 15, 2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 2... | Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... | Class I | Fresenius Kabi USA, LLC |
| Nov 15, 2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 2... | Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... | Class I | Fresenius Kabi USA, LLC |
| Nov 14, 2018 | Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by:... | Presence of Foreign Substance; metal shard found in tablet | Class II | Ascend Laboratories LLC |
| Nov 9, 2018 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... | Cross contamination with other products: This sub-recall is being initiated in support of the rec... | Class III | AMERICAN HEALTH PACKAGING |
| Nov 9, 2018 | Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl... | Labeling: Label mix-up - the label on the product may not match the formula in the bottle. | Class II | Ecolab Inc |
| Nov 9, 2018 | Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl o... | Labeling: Label mix-up - the label on the product may not match the formula in the bottle. | Class II | Ecolab Inc |
| Nov 8, 2018 | ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use v... | Labeling: Missing label; potential for missing primary container label on the vial. | Class III | Eli Lilly & Co |
| Nov 8, 2018 | INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx ... | Failed Stability Specification: out of specification for iron content. | Class II | ALLERGAN |
| Nov 7, 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... | Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 1... | Class II | Dr. Reddy's Laboratories, Inc. |
| Nov 7, 2018 | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... | Cross contamination with other products: Product is being recalled due to the potential presence ... | Class III | RemedyRepack Inc. |
| Nov 6, 2018 | Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... | Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... | Class III | Breckenridge Pharmaceutical, Inc. |
| Nov 6, 2018 | AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by:... | Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month ... | Class III | Takeda Development Center Americas, Inc. |
| Nov 6, 2018 | Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, ... | Presence of foreign substance: Product found to contain metal particles. | Class II | L. Perrigo Company |
| Nov 5, 2018 | puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115,... | Non-Sterility: Product manufactured under non-sterile production conditions. | Class I | Kadesh International |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufacture... | Cross Contamination with Other Products | Class II | Sandoz Inc |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distribu... | Cross Contamination with Other Products | Class II | Sandoz Inc |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciG... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactur... | Cross Contamination with Other Products | Class II | Sandoz Inc |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactur... | Cross Contamination with Other Products | Class II | Sandoz Inc |
| Nov 2, 2018 | curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Ep... | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... | Class II | Bound Tree Medical, LLC |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 ... | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... | Class II | Bound Tree Medical, LLC |
| Nov 2, 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo... | Cross Contamination with Other Products | Class III | Sandoz Inc |
| Nov 2, 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ... | Cross Contamination with Other Products | Class III | Sandoz Inc |
| Nov 2, 2018 | Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarn... | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... | Class II | Bound Tree Medical, LLC |
| Nov 2, 2018 | Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contai... | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use... | Class II | Bound Tree Medical, LLC |
| Nov 1, 2018 | Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe... | Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May... | Class III | Bound Tree Medical, LLC |
| Nov 1, 2018 | Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Sandoz, Inc |
| Nov 1, 2018 | curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains... | Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 e... | Class II | Bound Tree Medical, LLC |
| Oct 31, 2018 | BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in n... | Lack of Assurance of Sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen P... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 29, 2018 | Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen P... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 29, 2018 | GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), ... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 ple... | Failed Impurities/Degradation Specifications; out of specification results observed for other ind... | Class III | Akorn, Inc. |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Ph... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 29, 2018 | GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured b... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30),... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in... | Defective Container: vial defect was identified that could potentially impact the container closu... | Class II | GE Healthcare Inc. Life Sciences |
| Oct 29, 2018 | Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-11... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 26, 2018 | Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), F... | Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and ... | Class I | Dr. Reddy's Laboratories, Inc. |
| Oct 26, 2018 | deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl.... | CGMP Deviations: Product was released to market prior to microbiological testing. | Class II | S.C. Johnson Professional |
| Oct 26, 2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... | Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability... | Class III | RemedyRepack Inc. |
| Oct 26, 2018 | Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8... | CGMP Deviations: Product was released to market prior to microbiological testing. | Class II | S.C. Johnson Professional |
| Oct 24, 2018 | Irbesartan Bulk Active Pharmaceutical Ingredient. | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | Aurobindo Pharma Limited (Unit I) |
| Oct 23, 2018 | Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg,... | Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont... | Class II | Janssen Pharmaceuticals, Inc. |
| Oct 23, 2018 | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28... | Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont... | Class II | Janssen 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.