Browse Drug Recalls

136 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 136 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 136 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Dec 31, 2025	Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only,...	Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets ...	Class II	Alvogen, Inc
Oct 17, 2025	Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet f...	Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly state...	Class II	Aero Healthcare
Oct 1, 2025	ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distribu...	Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to ind...	Class II	Church & Dwight Co., Inc.
Sep 23, 2025	Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Man...	Product Mix-up	Class II	ACME UNITED CORPORATION
Aug 11, 2025	Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist...	Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained...	Class II	Lannett Company Inc.
Aug 5, 2025	Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIEL...	Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/W...	Class III	Haleon US Holdings LLC
Jun 27, 2025	Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 milli...	Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labele...	Class I	Sandoz Inc
Jun 27, 2025	Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or ...	Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vial...	Class I	Sandoz Inc
Mar 13, 2025	Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ...	LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ...	Class I	Dr. Reddy's Laboratories, Inc.
Dec 18, 2024	Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops,...	LABELING: LABEL MIX-UP	Class III	AvKARE
Dec 18, 2024	Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant...	LABELING: LABEL MIX-UP	Class III	AvKARE
Oct 18, 2024	Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for...	Labeling: Label Mix-Up	Class II	AvKARE
Oct 18, 2024	Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f...	Labeling: Label Mix-Up	Class II	AvKARE
Aug 20, 2024	Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g...	LABELING: LABEL MIX-UP.	Class III	Elevate Oral Care
Jul 18, 2024	Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid ...	Label mix-up: Carton incorrectly labeled.	Class III	Granules Consumer Health Inc.
Jul 8, 2024	Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b...	Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found ...	Class I	Hikma Pharmaceuticals USA Inc.
Jun 21, 2024	Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package...	Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec...	Class I	A-S Medication Solutions LLC
May 31, 2024	Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of ho...	Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferr...	Class III	Washington Homeopathic Products, Inc.
Apr 29, 2024	Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,...	Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.	Class I	Hikma Injectables USA Inc
Apr 20, 2024	Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi...	Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate	Class I	Revive Rx LLC dba Revive Rx Pharmacy
Jan 4, 2024	Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,...	Labeling: Label Mix-up	Class I	Azurity Pharmaceuticals, Inc.
Nov 10, 2023	Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25...	Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL ...	Class III	Fagron Compounding Services
Nov 9, 2023	LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% To...	Product Mix-up: Incorrect Product Formulation	Class III	Right Value Drug Stores, LLC dba Carie Boyd's P...
Nov 7, 2023	Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: ...	Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen	Class II	Glenmark Pharmaceuticals Inc., USA
Nov 7, 2023	Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glen...	Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen	Class II	Glenmark Pharmaceuticals Inc., USA
Aug 25, 2023	Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/D...	Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,...	Class I	Marlex Pharmaceuticals, Inc.
Aug 25, 2023	Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Di...	Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,...	Class II	Marlex Pharmaceuticals, Inc.
Aug 11, 2023	Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NE...	Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% ...	Class II	AVKARE LLC
Aug 10, 2023	hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v f...	Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons label...	Class II	Colgate Palmolive Company
Jun 6, 2023	GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisit...	Labeling: Label Mix-up	Class III	HF Acquisition Co LLC
May 31, 2023	ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on...	Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we...	Class I	The Harvard Drug Group LLC dba Major Pharmaceut...
Apr 20, 2023	G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric...	Product mix-up: incorrect product was found inside the G-Supress DX product carton.	Class I	Novis PR, LLC dba Kramer Novis
Mar 9, 2023	JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-01...	Labeling: Label Mix-up	Class II	Boehringer Ingelheim Pharmaceuticals, Inc.
Dec 16, 2022	Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton...	Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-coun...	Class II	Hikma Pharmaceuticals USA Inc.
Sep 19, 2022	Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manu...	Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 ...	Class III	UNICHEM PHARMACEUTICALS USA INC
Jun 24, 2022	Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distribute...	Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affix...	Class II	Vi-Jon, LLC
Jun 17, 2022	Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx ...	Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta...	Class I	Bryant Ranch Prepack, Inc.
Jun 17, 2022	Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx ...	Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta...	Class I	Bryant Ranch Prepack, Inc.
Mar 21, 2022	The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (5...	Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Pep...	Class II	Revive Personal Products Company
Mar 11, 2022	Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit...	Labeling: Label Mix-Up	Class II	DASH Pharmaceuticals LLC
Mar 8, 2022	Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottle...	Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydroc...	Class I	Jubilant Cadista Pharmaceuticals, Inc.
Mar 2, 2022	HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 4...	Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol a...	Class II	Vi-Jon, Inc.
Nov 29, 2021	Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, ...	Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5...	Class II	Denver Solutions, LLC DBA Leiters Health
Nov 19, 2021	Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count...	Product Mix-up	Class II	Ascent Pharmaceuticals, Inc.
Sep 28, 2021	The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL O...	Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Men...	Class II	Revive Personal Products Company
Sep 9, 2021	Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Di...	Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrec...	Class II	Vi-Jon, Inc.
Aug 24, 2021	Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit...	Product Mix-up: Incorrect diluent component included in the kit.	Class I	Azurity Pharmaceuticals, Inc.
May 3, 2021	1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose v...	Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U...	Class I	PFIZER, INC
May 3, 2021	0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL ...	Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U...	Class I	PFIZER, INC
Apr 14, 2021	Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a...	Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.	Class II	Fresenius Medical Care, North America

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.