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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Oct 1, 2025 ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distribu... Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to ind... Class II Church & Dwight Co., Inc.
Jan 24, 2022 Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HC... cGMP deviations Class II Ultra Seal Corporation
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight 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.