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Browse Drug Recalls

22 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 22 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 22 FDA drug recalls.

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DateProductReasonClassFirm
Jan 2, 2019 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in... Subpotent Class II PharMEDium Services, LLC.
Dec 5, 2018 Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in... Sub-potent Class II Pharmedium Services, LLC
Dec 5, 2018 Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% i... Sub-potent Class II Pharmedium Services, LLC
Jul 24, 2018 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Jul 24, 2018 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Jul 24, 2018 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium S... CGMP deviations: Product was released while a hood certification discrepancy was being investigated. Class II PharMEDium Services, LLC
Oct 13, 2017 Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packa... Superpotent drug: out of specification result for potency Class II PharMEDium Services, LLC.
Sep 1, 2017 Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL b... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag, Rx Onl... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL b... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx On... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL b... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx O... Subpotent Drug Class II Pharmedium Services, LLC
Sep 1, 2017 Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 ... Subpotent Drug 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.