Browse Drug Recalls

1,141 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,141 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 1,141 FDA drug recalls in 2017.

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DateProductReasonClassFirm
Mar 6, 2017 RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. B... Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsul... Class III Dr. Reddy's Laboratories, 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.
Mar 1, 2017 Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectr... Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial conta... Class II Signature Club A Ltd
Feb 28, 2017 Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicat... CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. Class III G & W Laboratories, Inc.
Feb 24, 2017 Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles... Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potas... Class III Citron Pharma Llc
Feb 23, 2017 Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 3... Presence of Foreign Substance: foreign material found in the bulk inventory. Class II Mckesson Packaging Services
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 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 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 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 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 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 Atropine 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 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 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 Meperidine 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 Ketamine HCl 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 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 NOVA 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 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 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.
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 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 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 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 Famotidine 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 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 Diltiazem 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only,... Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance.... Class II Endo Pharmaceuticals, 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.