Browse Drug Recalls

65 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 65 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 65 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Dec 16, 2020	Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx ...	Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in...	Class III	US Compounding Inc
Nov 25, 2020	Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospit...	Labelling: Missing label.	Class III	US Compounding Inc
Jan 29, 2019	Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compoun...	Lack of assurance of sterility.	Class II	US Compounding Inc
Jan 24, 2019	LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date an...	Class II	US Compounding Inc
Jul 25, 2016	Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) ...	Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia	Class I	US Compounding Inc
Sep 12, 2015	Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC inj...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Inj...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Re...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Re...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compou...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM I...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injec...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT I...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Inje...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL U...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical op...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-A...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection,...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Region...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM In...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Op...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, R...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx o...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL),...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 m...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic us...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Inje...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For T...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Inje...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydr...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injec...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Us...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL,...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounde...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ al...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regi...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For To...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection ...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding Inc
Sep 12, 2015	Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only,...	Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex...	Class II	US Compounding 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.