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Browse Drug Recalls

10 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 10 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 10 FDA drug recalls.

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DateProductReasonClassFirm
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v an... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Jul 23, 2021 PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable Int... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Profession... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Pr... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable In... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable Inter... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professiona... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packag... SubPotent: Out of Specification Class II Professional Disposables 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.