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Browse Drug Recalls

515 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 515 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 515 FDA drug recalls.

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DateProductReasonClassFirm
May 6, 2016 Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hosp... Presence of Particulate Matter: Cardboard Class II Hospira Inc.
May 5, 2016 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Me... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 2... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 m... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chlor... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 5... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, 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.