FDA Drug Recall Tracker 2026 - Latest US Drug Recalls & Enforcement Reports

Reported	Class	Product	Recalling Firm
01 Jul 2026	Class II	LACOSAMIDE Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets…	Annora Pharma Private Limited
01 Jul 2026	Class II	CORLANOR Presence of Foreign Substance.	Amgen, Inc.
01 Jul 2026	Class II	CORLANOR Presence of Foreign Substance.	Amgen, Inc.
01 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.	CareFusion 213, LLC
01 Jul 2026	Class II	FENOFIBRATE CGMP Deviations	Ajanta Pharma USA Inc
01 Jul 2026	Class II	SENSIPAR CGMP Deviations	Amgen, Inc.
01 Jul 2026	Class II	POVI-ONE sub potency	Elevate Oral Care
01 Jul 2026	Class II	DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30… CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Direct Rx
01 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.	CareFusion 213, LLC
01 Jul 2026	Class II	Total Parental Nutrition - Pediatric PN Patient-Specific TP… Incorrect product formulation: bag did not contain copper and famotidine per label.	Central Admixture Pharmacy Services, Inc.
01 Jul 2026	Class II	METHYLERGONOVINE MALEATE Subpotent Drug	The Harvard Drug Group LLC
01 Jul 2026	Class II	PReye Vitamin See Antioxidant Preservative Free Eye Drops, … Lack of Assurance of Sterility	PReye LLC
01 Jul 2026	Class I	CHLORAPREP ONE-STEP Non-Sterility: Due to presence of Aspergillus penicillioides.	CareFusion 213, LLC
01 Jul 2026	Class III	HYDROXYZINE HYDROCHLORIDE Presence of foreign substance	ANI Pharmaceuticals, Inc.
01 Jul 2026	Class II	PERAMPANEL Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.	SUN PHARMACEUTICAL INDUSTRIES INC
01 Jul 2026	Class II	SENSIPAR CGMP Deviations	Amgen, Inc.
01 Jul 2026	Class II	SENSIPAR CGMP Deviations	Amgen, Inc.
01 Jul 2026	Class I	CHLORAPREP ONE-STEP Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper li…	CareFusion 213, LLC
24 Jun 2026	Class II	HEALTH-TEC TOPICAL ANESTHETIC Defective container:may contain bottles with incomplete seals	Keystone Industries
24 Jun 2026	Class II	Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tu… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	PURELIFE TOPICAL ANESTHETIC Defective container:may contain bottles with incomplete seals	Keystone Industries
24 Jun 2026	Class II	Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Z… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equ… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bac… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, … CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, … Subpotent Drug	IntegraDose Compounding Services LLC
24 Jun 2026	Class II	CHLORTHALIDONE Failed Dissolution Specifications	Inventia Healthcare Limited
24 Jun 2026	Class II	QUALA TOPICAL ANESTHETIC GEL Defective container:may contain bottles with incomplete seals	Keystone Industries
24 Jun 2026	Class II	Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrima… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tub… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g)… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY … Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023	PAI Holdings LLC
24 Jun 2026	Class II	VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY… Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023	PAI Holdings LLC
24 Jun 2026	Class II	VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY … Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023	PAI Holdings LLC
24 Jun 2026	Class II	ARIPIPRAZOLE Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.	Ajanta Pharma USA Inc
24 Jun 2026	Class II	BURKHART TOPICAL ANESTHETIC Defective container:may contain bottles with incomplete seals	Keystone Industries
24 Jun 2026	Class II	DENTAL CITY TOPICAL ANESTHETIC Defective container:may contain bottles with incomplete seals	Keystone Industries
24 Jun 2026	Class II	Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL Defective container:may contain bottles with incomplete seals	Keystone Industries
24 Jun 2026	Class II	Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (2… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class III	FOCALIN Labeling: Incorrect or Missing Lot and/or Exp Date	Sandoz Inc
24 Jun 2026	Class II	Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 … CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	ALYACEN 1/35 Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.	Glenmark Pharmaceuticals Inc., USA
24 Jun 2026	Class II	Circle K, triple antibiotic ointment, Bacitracin Zinc (400 … CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	BUPRENORPHINE HYDROCHLORIDE Crystallization; identified as Buprenorphine free base	Par Health USA, LLC
24 Jun 2026	Class II	PEARSON TOPICAL ANESTHETIC Defective container:may contain bottles with incomplete seals	Keystone Industries
24 Jun 2026	Class II	VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY… Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023	PAI Holdings LLC
24 Jun 2026	Class II	Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) … CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
24 Jun 2026	Class II	Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packet… CGMP Deviations; deficiencies observed during FDA inspection	Dabur India Limited
17 Jun 2026	Class II	MINOCYCLINE HYDROCHLORIDE Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test ana…	Ascend Laboratories, LLC
17 Jun 2026	Class I	Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged … Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging p…	Haleon US Holdings LLC
17 Jun 2026	Class I	BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion R… Microbial Contamination of Non-Sterile Products	BEEKEEPER'S NATURALS USA INC.
17 Jun 2026	Class II	BUDESONIDE Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown …	SUN PHARMACEUTICAL INDUSTRIES INC
17 Jun 2026	Class II	ZEP ALCOHOL SANITIZER Microbial contamination of sterile products	Zep Inc
17 Jun 2026	Class II	DULOXETINE CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Breckenridge Pharmaceutical, Inc.
17 Jun 2026	Class III	EPINEPHRINE Failed Impurities/Degradations Specifications	Fresenius Kabi USA, LLC
17 Jun 2026	Class I	DOXORUBICIN HYDROCHLORIDE Presence of Particulate matter: Particulate matter identified as glass.	SUN PHARMACEUTICAL INDUSTRIES INC
17 Jun 2026	Class II	DULOXETINE CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Breckenridge Pharmaceutical, Inc.
17 Jun 2026	Class III	PRIMIDONE Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the AP…	Amneal Pharmaceuticals, LLC
17 Jun 2026	Class II	NIACIN Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for st…	Golden State Medical Supply Inc.
10 Jun 2026	Class II	HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Table… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	LIDOCAINE HYDROCHLORIDE Lack of Assurance of Sterility	Spectra Medical Devices, Llc
10 Jun 2026	Class II	HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 7… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	EXTRA STRENGTH ANTACID Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class III	LIDOLOG KIT Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan	Eugia US LLC
10 Jun 2026	Class II	TOPCARE ULTRA STRENGTH ANTACID ASSORTED FRUIT Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	GOODSENSE ULTRA STRENGTH ANTACID ASSORTED FRUIT Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Table… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calciu… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	ULTRA STRENGTH ANTACID ASSORTED BERRIES Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	EQU ULTRA STRENGTH ANTACID ASSORTED FRUIT 171AF Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	GOODSENSE EXTRA STRENGTH ANTACID Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	EQUALINE EXTRA STRENGTH ASSORTED BERRY ANTACID Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	ULTRA STRENGTH ANTACID ASSORTED FRUIT Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx… Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product unde…	SUN PHARMACEUTICAL INDUSTRIES INC
10 Jun 2026	Class II	Extra strength Antacid Calcium Carbonate 750 mg, chewable t… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	AMLODIPINE AND OLMESARTAN MEDOXOMIL Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications	Ascend Laboratories, LLC
10 Jun 2026	Class II	DULOXETINE CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable …	Asclemed USA Inc.
10 Jun 2026	Class II	TOPCARE EXTRA STRENGTH ANTACID Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	FAMILY WELLNESS ULTRA STRENGTH ASSORTED FRUIT ANTACID Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRE… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calc… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	HEB EXTRA STREGTH ANTACID Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 10… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx… Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product unde…	SUN PHARMACEUTICAL INDUSTRIES INC
10 Jun 2026	Class II	GOOD NEIGHBOR PHARMACY ANTACID Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	NIACIN Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.	Lannett Company Inc.
10 Jun 2026	Class II	FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Ca… Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
10 Jun 2026	Class II	KIRKLAND ULTRA STREGTH ANTACID 171AB Presence of foreign substance: small metallic particles in chewable tablets.	Guardian Drug Co. Inc.
03 Jun 2026	Class III	NICOTINE Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specification…	AVEVA Drug Delivery Systems, Inc.
03 Jun 2026	Class III	PRED MILD Failed Stability Specifications	AbbVie Inc.
27 May 2026	Class II	ATOMOXETINE Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.	Safecor Health, LLC
27 May 2026	Class II	fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50… Subpotent Drug	IntegraDose Compounding Services LLC
27 May 2026	Class II	ERYTHROMYCIN CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit	Zydus Pharmaceuticals (USA) Inc
27 May 2026	Class II	LIRAGLUTIDE Presence of particulate matter: a white thread-like structure in the cartridge	Lupin Pharmaceuticals Inc.
27 May 2026	Class II	ERYTHROMYCIN CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit	Zydus Pharmaceuticals (USA) Inc
27 May 2026	Class III	PRIMIDONE Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.	Amerisource Health Services LLC
27 May 2026	Class III	PRIMIDONE Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.	Golden State Medical Supply Inc.
27 May 2026	Class III	PRIMIDONE Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.	Golden State Medical Supply Inc.

Source: openFDA Drug Enforcement API, U.S. Food & Drug Administration - Class I is the most serious (reasonable probability of serious harm or death), Class III the least. openFDA data is provided as-is and unvalidated. See our FDA Approvals Tracker for new drug approvals, or the EMA Approvals Tracker for the EU market.