Browse Drug Recalls
2,021 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,021 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 2,021 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two pla... | Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the... | Class III | L. Perrigo Company |
| 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 |
| Jun 1, 2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged ... | Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import ... | Class II | American Pharmaceutical Ingredients LLC |
| 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 18, 2017 | Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx on... | Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually ... | Class II | Forest Laboratories, LLC |
| May 5, 2017 | AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactu... | PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled w... | Class III | Ascend Laboratories LLC |
| Apr 20, 2017 | Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactur... | Labeling: Label Mixup; potentially mislabeled | Class II | C. O. Truxton |
| Apr 20, 2017 | Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured b... | Labeling: Label Mixup; potentially mislabeled | Class II | C. O. Truxton |
| 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: Label Mixup; potentially mislabeled | Class II | C. O. Truxton |
| Apr 20, 2017 | Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b... | Labeling: Label Mixup; potentially mislabeled | Class II | 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 17, 2017 | Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pi... | Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel.... | Class III | Fagron, Inc |
| Apr 17, 2017 | Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgel... | Subpotent: This product is being recalled due to low out of specification assay results at the 9... | Class III | P & L Development, LLC |
| 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 |
| Apr 6, 2017 | Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100... | Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... | Class II | PharMedium Services, Llc |
| Apr 6, 2017 | Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100... | Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... | Class II | PharMedium Services, Llc |
| Apr 3, 2017 | Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Dr... | Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information a... | Class II | Cell Distributors |
| Mar 28, 2017 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a... | Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Mar 20, 2017 | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638... | Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. | Class III | G & W Laboratories, Inc. |
| 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 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 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. |
| Feb 22, 2017 | Lidocaine 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 | 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. |
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.