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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
Dec 27, 2017 Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and a... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Adenosine Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Labetalol 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 Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all ... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Methadone 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 Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packag... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Succinylcholine Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all ... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and pack... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pac... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ephedrine Sulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Labetalol HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and al... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Glycopyrrolate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Oct 30, 2017 ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 ... Subpotent Drug 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 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
Sep 26, 2017 Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL ... Superpotent 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 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
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intrav... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL i... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in ... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Int... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intrav... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 2... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL In... Lack of Assurance of Sterility; media fill failure at manufacturer 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.