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Browse Drug Recalls

3 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3 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 3 FDA drug recalls.

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DateProductReasonClassFirm
Oct 28, 2020 Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 m... Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer ... Class I Lohxa LLC
Mar 25, 2019 Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.... Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Class II Lohxa LLC
Mar 25, 2019 Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. ... Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Class II Lohxa LLC

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.