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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Oct 24, 2016 UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: M... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration con... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 11... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 1... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals Inc
Oct 24, 2016 Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... Class II Burel Pharmaceuticals 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.