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Browse Drug Recalls

695 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 695 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 695 FDA drug recalls in PA.

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DateProductReasonClassFirm
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CAL... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with low c... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, p... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODI... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCI... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 5... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 41... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 8... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Serv... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central A... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, p... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL pe... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Servi... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 10... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Cen... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per ba... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, R... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCI... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCI... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL p... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low ca... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEP... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per ba... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial A... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per b... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixtur... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, package... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassiu... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 10... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Mar 20, 2023 Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged ... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) ... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-0... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepac... cGMP Deviations Class II RemedyRepack 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.