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Browse Drug Recalls

19 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 19 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 19 FDA drug recalls.

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DateProductReasonClassFirm
Jul 2, 2024 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorba... Defective container: potential for non-sealed pouches which can lead to product leakage. Class III Novel Laboratories, Inc. d.b.a Lupin Somerset
Feb 5, 2024 Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when rec... Labeling: Incorrect or Missing Package Insert Class II Lupin Pharmaceuticals Inc.
Dec 29, 2021 Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... Out-of-specification impurity test result observed at 18-month long term stability time point. Class III Lupin Pharmaceuticals Inc.
Jul 29, 2021 GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with F... Failed Stability Specification; Out of specification for Osmolarity Class II Novel Laboratories, Inc. d.b.a LUPIN
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufac... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Mar 19, 2019 Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chlor... Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon... Class II LUPIN SOMERSET
Jan 15, 2019 Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, ... Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated ou... Class II LUPIN SOMERSET
Dec 21, 2018 Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufa... Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specificat... Class II LUPIN SOMERSET
Oct 5, 2018 Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured... Failed Impurities/Degradation Specifications:Out of specification result noticed for total impuri... Class II LUPIN SOMERSET
Aug 23, 2018 Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, ... Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being... Class III LUPIN SOMERSET
Jun 28, 2018 Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufac... Subpotent Drug and Failed Content Uniformity. Class II LUPIN SOMERSET
May 24, 2018 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-coun... Labeling: Missing Label Class III LUPIN SOMERSET
Mar 5, 2018 Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5... Failed Impurities/Degradation Specifications Class III Novel Laboratories, Inc.
Feb 22, 2017 Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not f... Chemical Contamination Class III Novel Laboratories, Inc.
Jun 20, 2014 Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint F... Failed Impurity/Degradation Specification; 12-month stability time point Class III Novel Laboratories, 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.