Browse Drug Recalls

1,122 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,122 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 1,122 FDA drug recalls in 2023.

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Date	Product	Reason	Class	Firm
Jul 14, 2023	Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **l...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 m...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx onl...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION,...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCI...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethami...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low c...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Ba...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium,...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total vol...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total v...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, ...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV B...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Ce...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextros...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, ...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCI...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, tot...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200m...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx On...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, C...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, I...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, tot...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low ...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, tota...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 14, 2023	Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIU...	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Class II	Central Admixture Pharmacy Services, Inc.
Jul 13, 2023	Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil...	Lack of Assurance of Sterility	Class II	New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Jul 13, 2023	Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bot...	Presence of Foreign Substance: Metal embedded in a tablet.	Class II	SUN PHARMACEUTICAL INDUSTRIES INC
Jul 11, 2023	Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For I...	Lack of Assurance of Sterility	Class II	Sagent Pharmaceuticals
Jul 11, 2023	Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, la...	Lack of Assurance of Sterility	Class II	Sagent Pharmaceuticals
Jul 11, 2023	Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd...	Lack of Assurance of Sterility	Class II	Sagent Pharmaceuticals
Jul 11, 2023	Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem...	Failed Dissolution Specifications	Class II	Ascend Laboratories, LLC
Jul 10, 2023	PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60...	CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim...	Class II	New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023	Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic...	CGMP Deviation: impurities exceed allowable limits.	Class II	Tenn South Distillery LLC dba Big Machine Disti...
Jul 10, 2023	SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, A...	CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim...	Class II	New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023	Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Ph...	Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing	Class II	SUN PHARMACEUTICAL INDUSTRIES INC
Jul 10, 2023	ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Com...	CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim...	Class II	New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023	Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515...	CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim...	Class II	New England Life Care, Inc. dba Advanced Compou...
Jul 7, 2023	Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Jul 7, 2023	Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 m...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Jul 7, 2023	Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 ...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Jul 7, 2023	Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Jul 7, 2023	Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 m...	Lack of Assurance of Sterility	Class II	SterRx, LLC
Jul 5, 2023	0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B....	Lack of assurance of sterility: bags have the potential to leak.	Class II	B. Braun Medical Inc.
Jul 5, 2023	Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one ...	Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Jul 5, 2023	Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured B...	Failed Moisture Limits: Water (moisture) content above the approved product specifications.	Class II	Teva Pharmaceuticals USA Inc
Jul 3, 2023	Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multipl...	Presence of Particulate Matter: Particulate matter identified as fiber.	Class II	Accord Healthcare, 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.