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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Jun 27, 2014 fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chlori... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, ... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag,... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG ... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable ba... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Feb 13, 2014 BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-... Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPiv... Class II Healix Infusion Therapy, 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.