Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 20, 2017 | Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 03... | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... | Class II | Mylan Pharmaceuticals Inc. |
| Mar 17, 2017 | Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, D... | Presence of Particulate Matter: Glass | Class II | Shire |
| Mar 17, 2017 | LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL b... | Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. | Class II | Akorn, Inc. |
| Mar 15, 2017 | Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramusc... | Presence of Particulate Matter | Class II | Sun Pharmaceutical Industries, Inc. |
| Mar 15, 2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68... | Failed Dissolution Specifications; 9 month long term stability | Class II | Zydus Pharmaceuticals USA Inc |
| Mar 13, 2017 | Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Swit... | Superpotent Drug: An oversized tablet was found in a bottle. | Class II | Genentech Inc. |
| Mar 13, 2017 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 m... | Failed Dissolution Specifications | Class II | Akorn Inc |
| Mar 10, 2017 | Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Clar... | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... | Class II | Claris Lifesciences Inc |
| Mar 10, 2017 | Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only... | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... | Class II | Claris Lifesciences Inc |
| Mar 10, 2017 | Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, ... | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... | Class II | Claris Lifesciences Inc |
| Mar 10, 2017 | Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Clari... | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... | Class II | Claris Lifesciences Inc |
| Mar 8, 2017 | Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free... | CGMP Deviations | Class II | Isomeric Pharmacy Solution, LLC |
| Mar 8, 2017 | hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, pa... | Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. wer... | Class II | Mckesson Medical Surgical |
| Mar 7, 2017 | Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign lan... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | Tiger King tablets, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The K... | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets ... | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 7, 2017 | MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 7, 2017 | STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign lang... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class II | A&H Focal Inc. |
| Mar 6, 2017 | ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023... | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets ... | Class II | Zydus Pharmaceuticals USA Inc |
| Mar 6, 2017 | Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v flu... | Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli... | Class II | GSK Consumer Healthcare |
| Mar 2, 2017 | Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A... | Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonid... | Class II | Fougera Pharmaceuticals Inc. |
| Mar 1, 2017 | Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectr... | Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial conta... | Class II | Signature Club A Ltd |
| Feb 23, 2017 | Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 3... | Presence of Foreign Substance: foreign material found in the bulk inventory. | Class II | Mckesson Packaging Services |
| Feb 22, 2017 | Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only,... | Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance.... | Class II | Endo Pharmaceuticals, Inc. |
| Feb 22, 2017 | Methohexital Sodium all strengths, all dosage forms and all packaging, Rx On... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Onl... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only,... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Onl... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx O... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only,... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packag... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only,... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avell... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, ... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Av... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Av... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, A... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, ... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella ... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Succinylcholine Chloride all strengths, all dosage forms and all packaging, R... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, ... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Av... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and a... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma 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.