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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Oct 6, 2015 TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 2... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Ph... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 2... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy

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.