Browse Drug Recalls
15 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 15 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 15 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2020 | nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Dec 16, 2019 | NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ... | Subpotent Drug | Class III | Pharmedium Services, LLC |
| Dec 16, 2019 | NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ... | Subpotent Drug | Class III | Pharmedium Services, LLC |
| Dec 16, 2019 | NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ... | Subpotent Drug | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg p... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Sep 26, 2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Pharmedium Services, LLC |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | 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.