Browse Drug Recalls
1,141 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,141 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 1,141 FDA drug recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2017 | Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Phar... | Subpotent Drug | Class III | Fresenius Kabi USA, LLC |
| Mar 16, 2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Alle... | Failed Impurities/Degradation Specifications | Class III | Allergan Sales, LLC |
| 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 12, 2017 | EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for M... | Defective Delivery System; reports of the device failing to activate which could result in a pati... | Class I | Meridian Medical Technologies a Pfizer Company |
| Mar 12, 2017 | EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured ... | Defective Delivery System; reports of the device failing to activate which could result in a pati... | Class I | Meridian Medical Technologies a Pfizer Company |
| 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 | 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 8, 2017 | Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free... | CGMP Deviations | Class II | Isomeric Pharmacy Solution, LLC |
| Mar 7, 2017 | Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign lang... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manuf... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in f... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign lan... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer Inc |
| Mar 7, 2017 | Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manuf... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| 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 | Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx ... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, ... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Indian God Lotion Spray Bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate... | Class III | A&H Focal Inc. |
| Mar 7, 2017 | Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manuf... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign l... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | 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 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, 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 | Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, Inc |
| Mar 7, 2017 | DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in ... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer Inc |
| Mar 7, 2017 | Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreig... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900... | Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... | Class III | Pfizer Inc |
| Mar 7, 2017 | ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | A&H Focal Inc. |
| Mar 7, 2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... | Cross Contamination with another product:residual powder found in inlet air duct identified as so... | Class III | Alvogen, 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 | GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign lang... | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | 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 7, 2017 | MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an ... | Class I | 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 |
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.