Browse Drug Recalls

213 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 213 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 213 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Apr 13, 2022	Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only,...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmac...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 0409...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distribut...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sando...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG:...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each bl...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in ...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: ...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalatio...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer,...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG:...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx on...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Maj...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthc...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, M...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manu...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, M...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL s...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex c...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022	Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-2...	cGMP deviations: Temperature abuse	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Mar 15, 2022	Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manuf...	cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ...	Class II	Teligent Pharma, Inc.
Feb 7, 2022	Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by:...	Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Relat...	Class II	Teligent Pharma, Inc.
Nov 30, 2021	Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ...	Superpotent Drug	Class I	Teligent Pharma, Inc.
Nov 30, 2021	Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ...	Superpotent Drug: Minimally superpotent	Class II	Teligent Pharma, Inc.
Oct 12, 2021	Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl...	CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same...	Class II	Teligent Pharma, Inc.
Jul 27, 2021	Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine ...	Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A...	Class II	Perrigo Company PLC
Jul 27, 2021	Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine ...	Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A...	Class II	Perrigo Company PLC
May 26, 2021	Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Dist...	Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units b...	Class III	McKesson Corporation dba McKesson Drug Company
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gr...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Aug 23, 2019	Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carto...	Failed Impurities/Degradation Specifications	Class II	Aurolife Pharma, LLC
Aug 23, 2019	Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count carto...	Failed Impurities/Degradation Specifications	Class II	Aurolife Pharma, LLC
Jan 16, 2019	Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards,...	Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate S...	Class II	Rx Pak Division of McKesson Corporation
Aug 14, 2018	Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in box...	Supterpotent Drug	Class II	Mckesson Corporation
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 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	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
Feb 26, 2018	RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured ...	Failed Stability Specifications	Class II	Mckesson Packaging Services
Jan 29, 2018	Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o...	Subpotent Drug: Out of specification for assay (stability testing)	Class III	Mckesson Packaging Services
Sep 13, 2017	Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ...	Failed Impurities/Degradation Specifications.	Class III	Vi-Jon, Inc.
Aug 28, 2017	Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose card...	Failed moisture limits: Out of specification for moisture content.	Class III	Mckesson Packaging Services
May 30, 2017	BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Onl...	Failed Moisture Limits: Product tested out-of-specification for moisture content.	Class III	Mckesson Packaging Services
Mar 8, 2017	hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, pa...	Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. wer...	Class II	Mckesson Medical Surgical
Feb 23, 2017	Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 3...	Presence of Foreign Substance: foreign material found in the bulk inventory.	Class II	Mckesson Packaging Services
Jan 4, 2017	Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ...	Supotent: Out of Specification result for assay test during routine stability testing.	Class III	Mckesson Packaging Services
Sep 15, 2016	Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carto...	Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no prod...	Class III	Mckesson Packaging Services
Sep 8, 2016	Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cart...	Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but...	Class III	Mckesson Packaging Services
Apr 12, 2016	SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC...	Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.	Class III	Mckesson Packaging Services
Jan 8, 2016	Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HB...	Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre...	Class II	Perrigo Company PLC

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.