Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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Date	Product	Reason	Class	Firm
May 1, 2018	Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma...	GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio...	Class II	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018	Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma...	GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio...	Class II	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018	Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular...	Presence of Particulate Matter: confirmed customer report of the presence of visible particulate ...	Class I	AuroMedics Pharma LLC
May 1, 2018	Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intr...	Presence of Particulate Matter: confirmed customer report for presence of visible particulate mat...	Class I	AuroMedics Pharma LLC
Apr 30, 2018	Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 pa...	Failed Stability Specifications	Class III	Teva Pharmaceuticals USA
Apr 30, 2018	PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, ...	CGMP Deviations	Class II	Mylan Pharmaceuticals Inc.
Apr 30, 2018	PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 4...	CGMP Deviations	Class II	Mylan Pharmaceuticals Inc.
Apr 30, 2018	PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only,...	CGMP Deviations	Class II	Mylan Pharmaceuticals Inc.
Apr 27, 2018	Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. ...	Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have be...	Class II	Sanofi-Aventis U.S. LLC
Apr 26, 2018	Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggrega...	Lack of Assurance of Sterility	Class II	Coast Quality Pharmacy LLC
Apr 26, 2018	Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473...	Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to...	Class III	Sun Pharmaceutical Industries, Inc.
Apr 24, 2018	Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa...	Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F...	Class II	Prescript Pharmaceuticals, Inc.
Apr 24, 2018	Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vital...	Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum...	Class II	Vitalab Pharmacy, Inc
Apr 24, 2018	Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable...	Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum...	Class II	Vitalab Pharmacy, Inc
Apr 24, 2018	Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa...	Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F...	Class II	Prescript Pharmaceuticals, Inc.
Apr 24, 2018	Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile inj...	Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum...	Class II	Vitalab Pharmacy, Inc
Apr 24, 2018	Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, M...	cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was n...	Class II	Mylan Pharmaceuticals Inc.
Apr 24, 2018	Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, M...	cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not...	Class II	Mylan Pharmaceuticals Inc.
Apr 24, 2018	Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laborat...	Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F...	Class II	Prescript Pharmaceuticals, Inc.
Apr 24, 2018	Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01	CGMP Deviations	Class II	Mylan Pharmaceuticals Inc.
Apr 24, 2018	Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, steri...	Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum...	Class II	Vitalab Pharmacy, Inc
Apr 24, 2018	Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phe...	Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum...	Class II	Vitalab Pharmacy, Inc
Apr 24, 2018	Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannet...	Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F...	Class II	Prescript Pharmaceuticals, Inc.
Apr 24, 2018	Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01	CGMP Deviations	Class II	Mylan Pharmaceuticals Inc.
Apr 24, 2018	Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc	Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum...	Class II	Vitalab Pharmacy, Inc
Apr 24, 2018	Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct f...	Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F...	Class II	Prescript Pharmaceuticals, Inc.
Apr 23, 2018	Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,...	Failed Dissolution Specifications. High dissolution results were obtained during stability testing.	Class III	Mckesson Packaging Services
Apr 23, 2018	Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On...	Failed Dissolution Specifications. High dissolution results were obtained during stability testing.	Class III	Mckesson Packaging Services
Apr 23, 2018	Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottl...	Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was foun...	Class II	Dr. Reddy's Laboratories, Inc.
Apr 23, 2018	Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on...	Failed Dissolution Specifications. High dissolution results were obtained during stability testing.	Class III	Mckesson Packaging Services
Apr 20, 2018	Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-co...	Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg containe...	Class II	Exela Pharma Sciences LLC
Apr 19, 2018	Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-co...	Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimeth...	Class II	Sun Pharmaceutical Industries, Inc.
Apr 17, 2018	Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-...	Failed Dissolution Specification: Low dissolution outside of specifications	Class III	Rhodes Pharmaceuticals, L.P.
Apr 16, 2018	Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count bl...	Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxy...	Class I	Epic Products, LLC
Apr 13, 2018	Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx...	Subpotent Drug	Class II	Lyne Laboratories, Inc.
Apr 13, 2018	Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufac...	Subpotent Drug	Class II	Lyne Laboratories, Inc.
Apr 13, 2018	OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box ...	Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS...	Class III	Septodont Inc.
Apr 13, 2018	Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx...	Subpotent Drug	Class II	Lyne Laboratories, Inc.
Apr 13, 2018	Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed...	Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement o...	Class III	Boiron Inc.
Apr 12, 2018	Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by...	Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadal...	Class I	AMA Wholesale
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
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	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	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 10, 2018	Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 co...	Failed Stability Specifications	Class II	Pharmalucence, Inc.
Apr 10, 2018	Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00	Presence of Foreign Tablets/Capsules	Class III	Aidarex Pharmaceuticals LLC
Apr 10, 2018	Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 ...	cGMP deviations	Class III	Pharmedium Services, LLC
Apr 9, 2018	Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1....	Defective Delivery System: Out of specification for adhesive transfer.	Class II	Noven Pharmaceuticals, Inc.
Apr 9, 2018	Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf...	Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.	Class III	LEADIANT BIOSCIENCES, INC
Apr 6, 2018	Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott...	Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino...	Class III	Sandoz Incorporated

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.