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.

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DateProductReasonClassFirm
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.