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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
Mar 25, 2024 Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufa... Failed Impurities/Degradation Specifications Class III Novitium Pharma LLC
Mar 4, 2024 Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufact... Cross Contamination with Other Products:(mycophenolate mofetil). Class III Novitium Pharma LLC
Nov 6, 2019 GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-0... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Golden State Medical Supply Inc.
Nov 6, 2019 GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-0... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Golden State Medical Supply Inc.
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma 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.