Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Sep 10, 2021	Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufac...	Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the...	Class II	Piramal Critical Care, Inc.
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.
Sep 2, 2021	Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed ...	Labeling: Incorrect Instructions	Class II	RISING PHARMACEUTICALS
Aug 19, 2021	Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only,...	Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL act...	Class II	Eli Lilly & Company
Aug 12, 2021	Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (...	Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, the...	Class II	ANHUI WELCOME FOREIGN TRADE CO.,LTD.
Aug 6, 2021	Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For...	Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does ...	Class II	XELLIA PHARMACEUTICALS USA, LLC
Aug 6, 2021	Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, Fo...	Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does ...	Class II	XELLIA PHARMACEUTICALS USA, LLC
Aug 5, 2021	Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx o...	Labeling: Not elsewhere classified: Mislabeling	Class III	Hikma Pharmaceuticals USA Inc.
Jul 29, 2021	Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx L...	Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as...	Class II	SUN PHARMACEUTICAL INDUSTRIES INC
Jul 19, 2021	Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma...	Correct Labeled Product Mispack	Class II	Teligent Pharma, Inc.
Jul 19, 2021	Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent P...	Correct Labeled Product Mispack	Class II	Teligent Pharma, Inc.
Jul 14, 2021	Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4...	Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.	Class I	Qikmoov LLC
Jul 7, 2021	Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 5...	Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the ...	Class III	LNK International, Inc.
Jun 22, 2021	Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured...	Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate...	Class I	Ardil Comercial S.R.L.
Jun 8, 2021	Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded ...	Labeling: Incorrect Exp. Date: Incorrect BUD.	Class III	Prisma Health Outsourcing Facility
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
May 13, 2021	Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium n...	Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluori...	Class II	Accupac, Inc.
May 12, 2021	MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70...	Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR...	Class I	Global Sanitizers LLC
May 12, 2021	MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70...	Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR...	Class I	Global Sanitizers LLC
May 11, 2021	DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distribut...	Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label c...	Class I	DIBAR NUTRICIONAL S DE RL DE CV
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
May 3, 2021	Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 2...	Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 co...	Class III	Mylan Institutional LLC
Apr 26, 2021	Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg...	Lack of Assurance of Sterility	Class II	Teva Pharmaceuticals USA
Apr 21, 2021	Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Ph...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Heritage Pharmaceuticals Inc
Apr 15, 2021	Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medi...	cGMP deviations	Class II	Grace Healthcare Medical, 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
Mar 19, 2021	ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy...	CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel...	Class II	CareFusion 213, LLC
Mar 19, 2021	ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop...	Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled stor...	Class I	CareFusion 213, LLC
Mar 19, 2021	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop...	Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ...	Class II	CareFusion 213, LLC
Mar 19, 2021	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v...	Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ...	Class II	CareFusion 213, LLC
Mar 19, 2021	BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v...	Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ...	Class I	CareFusion 213, LLC
Mar 19, 2021	ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop...	CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel...	Class II	CareFusion 213, LLC
Mar 19, 2021	BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop...	Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ...	Class I	CareFusion 213, LLC
Mar 19, 2021	Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Bli...	Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed ...	Class III	Asclemed USA Inc. dba Enovachem Pharmaceuticals
Mar 19, 2021	ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy...	Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled stora...	Class I	CareFusion 213, LLC
Mar 17, 2021	Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: A...	Labeling: Label-mixup	Class I	Alembic Pharmaceuticals Limited
Mar 10, 2021	heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, A...	Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate...	Class I	PNHC, LLC.
Mar 2, 2021	Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottle...	Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 co...	Class I	A-S Medication Solutions LLC.
Feb 19, 2021	Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx...	Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosi...	Class III	Jubilant Cadista Pharmaceuticals, Inc.
Feb 17, 2021	Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Pres...	Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rath...	Class III	Edge Pharma, LLC
Feb 10, 2021	Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 2, 2021	Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Aut...	Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 m...	Class I	Apotex Corp.
Feb 2, 2021	Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automati...	Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 12...	Class I	Apotex Corp.
Feb 1, 2021	Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed...	Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled a...	Class II	Kimberly-Clark Corporation
Jan 28, 2021	Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose V...	Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled fo...	Class III	Accord Healthcare, Inc.
Jan 27, 2021	Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dos...	Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain t...	Class I	Meitheal Pharmaceuticals Inc
Jan 27, 2021	Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 636...	Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolact...	Class I	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 27, 2021	Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma...	Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact...	Class II	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 15, 2021	Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distribute...	Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ...	Class III	Calvin Scott & Company, 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.