Drugs
Not Yet Classified
Ongoing
Reported Sep 16, 2026
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Nationwide within the U.S
- Firm
- OurPharma LLC
- Recall began
- Sep 3, 2026
- Quantity
- 1,610 bags
- Codes
- Lot #: 101301260605, BUD: 12/9/2026.
- FDA IDs
- Not specified / event 99837
Drugs
Class III
Ongoing
Reported Sep 16, 2026
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Nationwide within the U.S
- Firm
- Ajanta Pharma USA Inc
- Recall began
- Aug 25, 2026
- Quantity
- 403,200 tablets
- Codes
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- FDA IDs
- D-0836-2026 / event 99733
Drugs
Class III
Ongoing
Reported Sep 16, 2026
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 078...
Subpotent Drug
USA Nationwide
- Firm
- ImprimisRx NJ LLC
- Recall began
- Aug 24, 2026
- Quantity
- 772 bottles
- Codes
- Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
- FDA IDs
- D-0835-2026 / event 99756
Drugs
Class I
Ongoing
Reported Sep 16, 2026
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
U.S. Nationwide.
- Firm
- Baxter Healthcare Corporation
- Recall began
- Aug 17, 2026
- Quantity
- 606 bags
- Codes
- Lot #: Y495066, Exp. Date July 31, 2027
- FDA IDs
- D-0850-2026 / event 99679
Food
Class II
Ongoing
Reported Sep 16, 2026
Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white label and gold screw on closure. UPC: 50040360530
Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.
Product is sold exclusively from the recalling firm's online website nationwide.
- Firm
- L-Nutra Inc
- Recall began
- Aug 7, 2026
- Quantity
- 8,529 jars
- Codes
- Lot code: L2755 Expiration: 02 Jan 2027
- FDA IDs
- H-1335-2026 / event 99675
Devices
Class II
Ongoing
Reported Sep 16, 2026
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
US Nationwide distribution.
- Firm
- Atrium Medical Corporation
- Recall began
- Aug 7, 2026
- Quantity
- 3618
- Codes
- 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Si...
- FDA IDs
- Z-3111-2026 / event 99680
Devices
Class II
Ongoing
Reported Sep 16, 2026
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
US Nationwide distribution.
- Firm
- Atrium Medical Corporation
- Recall began
- Aug 7, 2026
- Quantity
- 256
- Codes
- 1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
- FDA IDs
- Z-3113-2026 / event 99680
Devices
Class II
Ongoing
Reported Sep 16, 2026
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic han...
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Worldwide distribution - US Nationwide and the countries of Canada and European Union.
- Firm
- Lutronic Corporation
- Recall began
- Aug 6, 2026
- Quantity
- 1065
- Codes
- Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A01...
- FDA IDs
- Z-3110-2026 / event 99601
Devices
Class II
Ongoing
Reported Sep 16, 2026
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
- Firm
- Nipro Renal Soultions USA, Corporation
- Recall began
- Aug 5, 2026
- Quantity
- 3,286 cases
- Codes
- BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
- FDA IDs
- Z-3133-2026 / event 99573
Devices
Class II
Ongoing
Reported Sep 16, 2026
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Hemodialysis concentrates contain high endotoxin levels
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
- Firm
- Nipro Renal Soultions USA, Corporation
- Recall began
- Aug 5, 2026
- Quantity
- 2,327 cases
- Codes
- DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- FDA IDs
- Z-3134-2026 / event 99573
Devices
Class II
Ongoing
Reported Sep 16, 2026
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Hemodialysis concentrates contain high endotoxin levels
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
- Firm
- Nipro Renal Soultions USA, Corporation
- Recall began
- Aug 5, 2026
- Quantity
- 100 drums/1072 cases
- Codes
- LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
- FDA IDs
- Z-3136-2026 / event 99573
Devices
Class II
Ongoing
Reported Sep 16, 2026
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
US Nationwide distribution in the states of CA, GA, WA.
- Firm
- Windstone Medical Packaging, Inc.
- Recall began
- Jul 29, 2026
- Quantity
- 3,260 kits
- Codes
- UDI-DI:B098AMS12394B0; Lot Numbers: 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444,...
- FDA IDs
- Z-3138-2026 / event 99658
Devices
Class II
Ongoing
Reported Sep 16, 2026
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US...
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia,...
- Firm
- HeartSine Technologies Ltd
- Recall began
- Jul 27, 2026
- Quantity
- 11,912
- Codes
- 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI codes: 0506016712067 Serial Numbers: 22D91164357L22 22D91164989L22 22D91180808K23 23D98000415K23 23D98000597K...
- FDA IDs
- Z-3120-2026 / event 99568
Devices
Class II
Ongoing
Reported Sep 16, 2026
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...
- Firm
- C.R. Bard Inc
- Recall began
- Jun 25, 2026
- Quantity
- 12,463 trays/kits
- Codes
- Catalog Numbers / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611 899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610 899918 / 0080174102...
- FDA IDs
- Z-3114-2026 / event 98840
Devices
Class II
Ongoing
Reported Sep 16, 2026
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 008017410...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...
- Firm
- C.R. Bard Inc
- Recall began
- Jun 25, 2026
- Quantity
- 283883 trays/kits
- Codes
- Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 0080174102...
- FDA IDs
- Z-3115-2026 / event 98840
Devices
Class II
Ongoing
Reported Sep 16, 2026
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complet...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...
- Firm
- C.R. Bard Inc
- Recall began
- Jun 25, 2026
- Quantity
- 33850 units/kits
- Codes
- SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A3044...
- FDA IDs
- Z-3118-2026 / event 98840
Devices
Class II
Ongoing
Reported Sep 16, 2026
Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and W...
- Firm
- C.R. Bard Inc
- Recall began
- Jun 25, 2026
- Quantity
- 364
- Codes
- (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 Lot Number: NGKT2492 SureStep" Foley Tray System Bardex¿ IC Complete...
- FDA IDs
- Z-3119-2026 / event 98840
Drugs
Class III
Ongoing
Reported Sep 9, 2026
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus P...
Failed dissolution specifications.
US Nationwide.
- Firm
- Supernus Pharmaceuticals, Inc.
- Recall began
- Aug 31, 2026
- Quantity
- 11304 bottles
- Codes
- Lot# 2145283, Exp Date: 31-Mar-2030.
- FDA IDs
- D-0833-2026 / event 99767
Drugs
Class II
Ongoing
Reported Sep 9, 2026
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsip...
Presence of Foreign Tablets/Capsules
U.S. Nationwide
- Firm
- Teva Pharmaceuticals USA, Inc
- Recall began
- Aug 24, 2026
- Quantity
- 175,392 bottles
- Codes
- Lot: 1394026, Exp. 02/2028.
- FDA IDs
- D-0834-2026 / event 99734
Drugs
Class III
Ongoing
Reported Sep 9, 2026
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual...
Labeling: Label Mix-up
US Nationwide.
- Firm
- American Health Packaging
- Recall began
- Aug 19, 2026
- Quantity
- 10,953 cartons.
- Codes
- Lot # 1030023, Exp Date: 06/30/2027.
- FDA IDs
- D-0840-2026 / event 99674
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 600...
CGMP Deviations
US Nationwide; Puerto Rico; and Chile.
- Firm
- Baxter Healthcare Corporation
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot # NC193672, NC193795, Exp Date: 04/30/2028; Lot # NC194198, Exp Date: 05/31/2028.
- FDA IDs
- D-0811-2026 / event 99500
Drugs
Class II
Ongoing
Reported Sep 9, 2026
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthc...
CGMP Deviations
US Nationwide; Puerto Rico; and Chile.
- Firm
- Baxter Healthcare Corporation
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
- FDA IDs
- D-0813-2026 / event 99500
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield...
CGMP Deviations
US Nationwide; Puerto Rico; and Chile.
- Firm
- Baxter Healthcare Corporation
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot # NC185424, Exp Date: 2/12/2027; Lot # NC185479, Exp Date: 2/13/2027; Lot # NC193948, Exp Date: 10/23/2027.
- FDA IDs
- D-0815-2026 / event 99500
Drugs
Class II
Ongoing
Reported Sep 9, 2026
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Co...
CGMP Deviations
US Nationwide; Puerto Rico; and Chile.
- Firm
- Baxter Healthcare Corporation
- Recall began
- Aug 6, 2026
- Quantity
- N/A
- Codes
- Lot # NC193856, Exp Date: 04/18/2028.
- FDA IDs
- D-0821-2026 / event 99500
Drugs
Class I
Ongoing
Reported Sep 9, 2026
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only,...
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
USA Nationwide.
- Firm
- OPTIMAL BALANCE PHARMACY
- Recall began
- Aug 5, 2026
- Quantity
- 53 vials
- Codes
- Lot#: LG342009076, Beyond Use Date: 10/4/26
- FDA IDs
- D-0851-2026 / event 99662