Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.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 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Standard Starter TPN 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 | 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 | 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 | Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all... | 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 | Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and al... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Cardioplegic Solution Maintenance all strengths, all dosage forms and all pac... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | RECK PeriCapsular injection 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 | Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Amiodarone 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 | Calcium Gluconate 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 | 0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packagi... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Adenosine 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 | 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. |
| Feb 22, 2017 | Midazolam 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 | Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all pac... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all p... | 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 | 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. |
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.