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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Oct 11, 2022 NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN ... Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg Class III LNK International, Inc.
Jul 2, 2019 Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubri... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Sep 28, 2015 Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter un... Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Class III Perrigo Company PLC
Aug 23, 2013 Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, In... Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone... Class II Walgreens Co
Mar 16, 2013 "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simeth... Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count ... Class II Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

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.