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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
Jun 13, 2020 Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients:... Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent ... Class II Yusef Manufacturing Laboratories, LLC
Jun 3, 2020 Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradim... Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. Class II Yusef Manufacturing Laboratories, LLC
Mar 3, 2020 PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g... Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for ... Class II Yusef Manufacturing Laboratories, 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.