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Browse Drug Recalls

291 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 291 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 291 FDA drug recalls.

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DateProductReasonClassFirm
Mar 16, 2020 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare B... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
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 rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe,... 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
Mar 16, 2020 fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, Fo... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL B... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, F... 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
Jun 7, 2019 Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syri... Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the... Class I PharMEDium Services, LLC
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
Jun 5, 2018 HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in... Superpotent and Subpotent Class II PharMEDium Services, LLC
Apr 10, 2018 Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 ... cGMP deviations Class III Pharmedium Services, LLC
Feb 5, 2018 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe,... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 25... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Dec 27, 2017 Ropivacaine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Nicardipine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Methadone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all p... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all dos... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Lidocaine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Neostigmine Methylsulfate Injection in all strengths, all doses, and all pack... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Esmolol HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ketamine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Atropine Sulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and al... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Rocuronium Bromide in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and al... Lack of sterility assurance. 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.