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Browse Drug Recalls

99 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 99 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 99 FDA drug recalls.

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DateProductReasonClassFirm
Apr 26, 2019 HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% ... Sub-potency Class II Advanced Pharma Inc.
Mar 13, 2019 Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Ster... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Sol... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectabl... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Soluti... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable S... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile singl... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, Q... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Mar 13, 2019 Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 3... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Feb 6, 2019 Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of... Labeling: Incorrect expiration date. Class II Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Inje... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Jan 15, 2019 HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodiu... Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/5... Class II Advanced Pharma Inc.
Nov 29, 2018 Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable So... Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per ... Class I Advanced Pharma Inc.
Jun 20, 2018 fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL ... Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated ... Class II Advanced Pharma Inc.
Jan 5, 2018 MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (US... Subpotent Class I Advanced Pharma Inc.
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS ... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 22, 2017 QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (... Lack of Assurance of Sterility Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Steri... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... Subpotent Drug: found to be below the specification for labeled assay. Class I Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Feb 22, 2017 Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, A... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Av... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Av... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avell... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only,... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packag... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.

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.