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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
May 28, 2019 Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection,... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injectio... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at R... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature,... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 ... Lack of Processing Controls. Class II Synthetopes 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.