Browse Drug Recalls
2,029 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,029 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 2,029 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 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 | Morphine Sulfate 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 | 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 | 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 | Ephedrine Sulfate 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 | Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx ... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Ondansetron 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 | Sodium Citrate 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 | 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 | Nalbuphine 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 | 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 | Rocuronium Bromide 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 | 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 | Labetalol 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 | Dexmedetomidine HCl 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 | Heparin sodium 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 | 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 | 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 | 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 | 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 | Potassium Phosphate 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Magnesium Sulfate 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 | Norepinephrine Bitartrate 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 | Bupivacaine 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 | 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 | 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 | 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 | 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 | Neostigmine Methylsulfate 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 | Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avel... | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Class II | Advanced Pharma Inc. |
| Feb 22, 2017 | Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dos... | 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 | TPN Neonatal all strengths, all dosage forms and all packaging, Rx Only, Ave... | 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. |
| Feb 22, 2017 | Hydromorphone 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. |
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.