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Browse Drug Recalls

11 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 11 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 11 FDA drug recalls.

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DateProductReasonClassFirm
Oct 31, 2025 Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Inj... Defective container: cracked/broken cartridges Class II Novocol Pharmaceutical of Canada, Inc.
Oct 31, 2025 Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, U... Defective container: cracked/broken cartridges Class II Novocol Pharmaceutical of Canada, Inc.
Oct 31, 2025 OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a cart... Defective container: cracked/broken cartridges Class II Novocol Pharmaceutical of Canada, Inc.
Oct 31, 2025 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine... Defective container: cracked/broken cartridges Class II Novocol Pharmaceutical of Canada, Inc.
Oct 31, 2025 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI ... Defective container: cracked/broken cartridges Class II Novocol Pharmaceutical of Canada, Inc.
Oct 31, 2025 darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Me... Defective container: cracked/broken cartridges Class II Novocol Pharmaceutical of Canada, Inc.
Oct 31, 2025 Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [M... Defective container: cracked/broken cartridges Class II Novocol Pharmaceutical of Canada, Inc.
Nov 20, 2020 Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p... Labeling: Label mix-up Class III Novocol Pharmaceutical of Canada, Inc.
May 2, 2019 Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 c... Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printe... Class II Septodont Inc.
Apr 13, 2018 OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box ... Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS... Class III Septodont Inc.
Aug 14, 2013 Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For ... Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under... Class II Novocol Pharmaceutical of Canada

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.