Browse Drug Recalls
1,738 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,738 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 1,738 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 9, 2017 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... | Subpotent Drug: found to be below the specification for labeled assay. | Class I | Advanced Pharma Inc. |
| Jun 9, 2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... | Subpotent Drug: found to be below the specification for labeled assay. | Class I | Advanced Pharma Inc. |
| Jun 6, 2017 | ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsu... | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Class I | Andropharm, LLC |
| Jun 6, 2017 | ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and... | Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. | Class I | Andropharm, LLC |
| Jun 5, 2017 | EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ... | Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli... | Class I | Bristol-myers Squibb Company |
| May 31, 2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... | Class I | Teva Pharmaceuticals |
| May 25, 2017 | CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufa... | Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, t... | Class I | Brian P. Richardson |
| May 25, 2017 | BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx... | Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bott... | Class I | AstraZeneca Pharmaceuticals, LP |
| May 19, 2017 | Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distr... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product ... | Class I | DYNAMIC TECHNICAL FORMULATIONS |
| May 16, 2017 | Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewa... | Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last... | Class I | Lupin Limited (Unit 1) |
| May 5, 2017 | GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA anal... | Class I | Genetic Edge Compounds LLC |
| Apr 21, 2017 | Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Sing... | Presence of Particulate Matter: human hair found within an internal sample syringe. | Class I | Hospira Inc. |
| Apr 20, 2017 | Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured b... | Labeling: Label Mixup; potentially mislabeled | Class I | C. O. Truxton |
| Apr 20, 2017 | Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... | Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital... | Class I | C. O. Truxton |
| Apr 18, 2017 | ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsu... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 1... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, ... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplie... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count pa... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, suppl... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied i... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg val... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 co... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, suppli... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 13, 2017 | Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HP... | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... | Class I | Standard Homeopathic Company |
| Apr 13, 2017 | Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.000000000000... | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... | Class I | Standard Homeopathic Company |
| Mar 28, 2017 | LaBri's Body Health Atomic, 60 capsules | Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine. | Class I | Envy Me |
| 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Feb 16, 2017 | XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg ... | Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tada... | Class I | Organic Herbal Supply |
| Feb 8, 2017 | Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC... | Presence of Particulate Matter | Class I | X-Gen Pharmaceuticals Inc. |
| Feb 3, 2017 | Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, R... | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... | Class I | SCA Pharmaceuticals |
| Feb 3, 2017 | Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Onl... | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... | Class I | SCA Pharmaceuticals |
| Feb 3, 2017 | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only... | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... | Class I | SCA Pharmaceuticals |
| Feb 3, 2017 | Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, S... | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... | Class I | SCA Pharmaceuticals |
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.