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Browse Drug Recalls

24 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 24 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 24 FDA drug recalls.

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DateProductReasonClassFirm
Jun 18, 2019 Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, ... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), ... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL St... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premie... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SD... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Ba... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SD... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50m... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syri... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premie... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Sing... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. ... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Pre... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Jan 11, 2018 Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounde... Labeling: Label Error on Declared Strength Class II Premier Pharmacy Labs Inc
Aug 10, 2017 Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Inj... Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds c... Class II Premier Pharmacy Labs 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.