Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

12251–12275 of 53080

HighFDA (Drugs)·D-0958-2023·2023-08-09
Epinephrine IV solution bags recalled due to inadequate sterilization validation
Central Admixture Pharmacy Services is recalling 6,784 bags of Epinephrine IV solution nationwide because validation data for decontamination and sterilization processes is lacking, creating a potential contamination risk.
Product
EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0970-2023·2023-08-09
Vancomycin IV Bags Recalled Over Sterility Assurance Concerns Nationwide
Central Admixture Pharmacy Services is recalling vancomycin 2 g/500 mL IV bags nationwide due to lack of sterility assurance. Validation data for decontamination cycles is not available.
Product
vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1037-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 356 bags of cardioplegia solution distributed nationwide. The recall is due to lack of assurance of sterility, as validation data for decontamination cycles is lacking.
Product
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2256-2023·2023-08-09
Siemens Pro.specta Emission CT Systems Sensor Issue Reduces Image Resolution
Siemens Pro.specta CT imaging systems may produce reduced image quality due to sensors triggering earlier than expected, potentially affecting diagnostic accuracy. Affected units were distributed across the US and internationally.
Product
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
Category
Medical Device
Distribution
7 states
HighFDA (Food)·F-1354-2023·2023-08-09
San Marco Premium Dough recalled for undeclared soy flour allergen
Cassanos Inc is recalling San Marco Premium Dough on Parchment due to undeclared soy flour. Consumers with soy allergies who consume this product face allergic reaction risk.
Product
San Marco Premium Dough on Parchment: packaged as 8in, 14in
Category
Food
Distribution
9 states
HighFDA (Drugs)·D-0998-2023·2023-08-09
Neonatal TPN Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 420 bags of neonatal TPN containing amino acids and dextrose due to lack of assurance of sterility. Validation data for decontamination cycles was not available.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0982-2023·2023-08-09
FDA Recalls Neostigmine Injectable Syringes Due to Sterility Assurance Deficiency
FDA is recalling Central Admixture Pharmacy Services' neostigmine injectable syringes due to lacking validation data for sterilization decontamination cycles, raising concerns about product sterility.
Product
neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0963-2023·2023-08-09
IV Phenylephrine bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalled 9,432 IV bags containing phenylephrine due to lack of assurance of sterility and insufficient validation data for decontamination cycles. The product was distributed nationwide.
Product
PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1057-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled Due to Unvalidated Sanitization Cycles
Central Admixture Pharmacy is recalling HYDROmorphone injection syringes nationwide due to lack of validated sanitization cycles, which compromises sterility.
Product
HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0996-2023·2023-08-09
Neonatal TPN solution recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 296 bags of neonatal TPN starter solution due to lacking validation data for decontamination cycles, raising concerns about sterility assurance.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1317-2023·2023-08-09
Pistachios Recalled Due to Undeclared Tree Nuts, Peanuts, and Wheat
Houston Pecan Company recalls pistachios in 5-pound bags due to potential undeclared allergens: tree nuts, peanuts, and wheat. Affected products were purchased before May 25, 2023, and distributed in Texas and via online sales.
Product
Pistachios Halves & Pieces packaged in 5 pound bags; Pistachios Roasted & Salted packaged in 5 pound bags; Pistachios Raw packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2316-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel
Medline is recalling 6,733 custom procedural kits due to potential sterility failure in the Turkuaz ultrasound gel component. The gel may not meet required sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0949-2023·2023-08-09
Succinylcholine Injectable Syringes Recalled for Unvalidated Decontamination Cycles
Central Admixture Pharmacy Services recalls 26,208 succinylcholine injection syringes nationwide due to lack of validated sterilization procedures. The manufacturer lacks adequate validation data for decontamination cycles.
Product
succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2278-2023·2023-08-09
Medical X-ray Systems Image Intensifier Detachment Injury Risk
GE OEC Elite Systems with 9-inch Image Intensifier devices may detach during movement if subjected to impact force, potentially causing injury to personnel and bystanders.
Product
OEC Elite Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1316-2023·2023-08-09
Blanched Hazelnuts Recalled for Undeclared Allergens
Houston Pecan Company is recalling blanched hazelnuts in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross-contamination. Consumers with allergies to these ingredients should not consume the product.
Product
Blanched Hazelnuts packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Food)·F-1346-2023·2023-08-09
Cassano's Pizza King Dough Recalled for Undeclared Soy Flour
Cassano's The Pizza King Proprietary Dough is being recalled due to undeclared soy flour. Consumers with soy allergies who consume this product may experience allergic reactions.
Product
Cassano's The Pizza King Proprietary Dough: packaged as 6in, 9in, 12in, 14in, and 16in
Category
Food
Distribution
9 states
HighFDA (Drugs)·D-0978-2023·2023-08-09
Heparin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 11,824 bags of heparin IV solution nationwide. The recall is due to lack of assurance of sterility and missing validation data for decontamination cycles.
Product
heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1326-2023·2023-08-09
Papaya Sweetened Recalled for Undeclared Tree Nuts, Peanuts, and Wheat
Houston Pecan Company recalls Papaya Sweetened in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross contamination. Affected products were distributed in Texas and through internet sales.
Product
Papaya Sweetened packaged in 5 pound bags
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2318-2023·2023-08-09
Medical Procedural Kits Recalled Due to Ultrasound Gel Sterility Risk
Medline Industries is recalling 1,182 sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2314-2023·2023-08-09
Medline procedural kits with potentially non-sterile ultrasound gel recalled
Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. Kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1055-2023·2023-08-09
Hydromorphone Injection Syringes Recalled for Sterility Validation Deficiency
Central Admixture Pharmacy Services is recalling 2,389 hydromorphone injection syringes distributed nationwide due to lack of validation data for sterilization procedures, which prevents assurance of product sterility.
Product
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2324-2023·2023-08-09
Medline Medical Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure
Medline Industries recalls 19,907 procedural kits because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1013-2023·2023-08-09
Oxytocin IV bags recalled nationwide for insufficient sterility assurance
Central Admixture Pharmacy Services recalled 2,692 bags of oxytocin IV solution nationwide because the company lacks data needed to prove the sterilization process is effective.
Product
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2276-2023·2023-08-09
OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall
The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.
Product
OEC 9800 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1319-2023·2023-08-09
Roasted Peanuts Recalled for Undeclared Tree Nuts, Peanuts, and Wheat
Houston Pecan Company is recalling roasted peanuts purchased before May 25, 2023, for undeclared allergen cross-contamination with tree nuts, peanuts, and wheat. The products were sold in Texas and through internet sales.
Product
Granulated Peanuts Roasted packaged in 5 pound bags; Virginia Peanuts Roasted NO SALT packaged in 5 pound bags; Spanish Peanuts Roasted & Salted packaged in 5 pound bags;
Category
Food
Distribution
1 state