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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Jul 7, 2025 Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen,... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2021 Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 5... Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the ... Class III LNK International, Inc.
Aug 23, 2019 Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton,... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Feb 7, 2014 Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephed... Defective Container: An unacceptable level of blister defects have been identified in Loratadine ... Class II Ohm Laboratories, Inc.
Sep 13, 2013 Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intrave... Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Ameri... Class II AmeriSource Bergen
Sep 13, 2013 Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intrav... Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Ameri... Class II AmeriSource Bergen

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.