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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
Nov 14, 2024 Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister ... CGMP Deviations: Released product should have been rejected. Class II LNK International, Inc.
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.
Aug 4, 2022 Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blist... Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate... Class III LNK International, Inc.
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.
Jul 10, 2019 Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berr... Microbial contamination of non-sterile product Class II LNK International, Inc.
Jul 18, 2012 Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Ace... Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free ... Class II LNK International, 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.