Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jan 15, 2020	Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM ...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/M...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, M...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABL...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIA...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 25...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Sh...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020	Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ...	Lack of Assurance of Sterility	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Dec 20, 2019	FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (7...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infu...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 5...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance I...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusi...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance In...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713)...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713...	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	Lack of sterility assurance.	Class II	Assurance Infusion
Dec 20, 2019	FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533...	Lack of sterility assurance.	Class II	Assurance Infusion

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.