Browse Drug Recalls
520 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 520 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 520 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 24, 2017 | Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package ... | Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. Th... | Class I | Hospira Inc., A Pfizer Company |
| Aug 15, 2016 | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be ... | Discoloration: Firm received complaints of product discoloration and particulates. | Class II | Hospira Inc. |
| Aug 4, 2016 | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Sing... | Presence of particulate matter: Confirmed customer report for the presence of particulate matter ... | Class I | Hospira Inc., A Pfizer Company |
| Jun 23, 2016 | Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake ... | Crystallization: Product contains particulate identified to be crystallized active ingredient. | Class II | Hospira Inc. |
| Jun 13, 2016 | Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - ... | Presence of Particulate Matter; The firm received two product complaints for small, dark particul... | Class II | Sagent Pharmaceuticals Inc |
| 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 |
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.