Hazard

Sterility Assurance recalls

663 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 663
Critical: 0
Severe: 261
Most recent: 2026-08-26

Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility assurance recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

301–325 of 663

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 (Drugs)·D-0990-2023·2023-08-09
Potassium Phosphate IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling potassium phosphate intravenous bags due to lack of sterility assurance and missing validation data for decontamination processes. The recall affects 234 bags distributed nationwide.
Product
potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1001-2023·2023-08-09
FDA Recalls Neonatal TPN Starter Bag for Lacking Sterility Assurance
Central Admixture Pharmacy Services recalls 68 neonatal TPN starter bags nationwide due to lack of validation data for decontamination cycles, posing a contamination risk.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% 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: 72196-0427-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0957-2023·2023-08-09
Epinephrine IV Bags Recalled Due to Unvalidated Sterility Process
Central Admixture Pharmacy Services is recalling 333 units of epinephrine 2 mg in dextrose 5% IV bags because validation data for sterilization procedures is lacking, raising concerns about product sterility assurance.
Product
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
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-1053-2023·2023-08-09
FDA Recalls Fentanyl Syringes Due to Sterility Validation Concerns
Central Admixture Pharmacy Services is recalling 1,669 fentanyl syringes nationwide due to lack of validation data for sanitization cycles, preventing assurance of product sterility.
Product
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1068-2023·2023-08-09
Morphine Injection Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling morphine injections nationwide due to inadequate validation of sterilization procedures, which poses a potential sterility risk.
Product
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2
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-1069-2023·2023-08-09
Injectable Fentanyl-Bupivacaine Mixture Recalled for Sterility Validation Failure
Central Admixture Pharmacy Services recalls 295 bags of injectable fentanyl-bupivacaine solution nationwide because the sterilization process lacked proper validation documentation.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1063-2023·2023-08-09
Fentanyl Injectable Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 1,044 bags of fentanyl injectable solution due to lack of validated sanitization procedures that could compromise sterility assurance. The product affects healthcare facilities nationwide.
Product
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1060-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.
Product
HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0975-2023·2023-08-09
FDA Recalls oxyTOCIN IV Bags Over Sterility Assurance Failure
FDA recalled 751 bags of oxyTOCIN added to Lactated Ringer's IV solution nationwide due to lack of validation data for decontamination cycles, which left sterility assurance unconfirmed.
Product
oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1
Category
Drug
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 (Drugs)·D-1071-2023·2023-08-09
Ketamine Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 2,994 syringes of ketamine injection distributed nationwide due to lack of validated sterilization procedures that ensure product sterility.
Product
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1044-2023·2023-08-09
HYDROmorphone Injectable Syringes Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services Inc is recalling HYDROmorphone injectable syringes because sterilization cycles were not validated. The recall affects 2,717 units distributed nationwide.
Product
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1025-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags distributed nationwide.
Product
CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0967-2023·2023-08-09
Vancomycin IV Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 6,772 bags of vancomycin IV solution nationwide due to lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product
vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0954-2023·2023-08-09
EPINEPHrine IV bags recalled nationwide due to lack of sterility assurance
Central Admixture Pharmacy Services is recalling 9,121 epinephrine IV bags distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Product
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1038-2023·2023-08-09
Cardioplegia Solution Recalled Due to Inadequate Sterility Assurance
Central Admixture Pharmacy Services is recalling cardioplegia solution IV bags nationwide due to lack of validated sterilization processes. The recall affects 184 bags from two lots.
Product
CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1054-2023·2023-08-09
Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling approximately 2,082 fentanyl injectable syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0936-2023·2023-08-02
Oxacillin for Injection recalled nationwide due to sterility concerns
Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.
Product
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0930-2023·2023-07-26
Sodium Bicarbonate Injectable Solution Recalled for Sterility Assurance Issues
SterRx is recalling 137,304 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide because the manufacturer cannot assure the product meets sterility standards. Affected lots have expiration dates from July 2023 through February 2024.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0721-2023·2023-05-31
Vancomycin and Dextrose Injection Sterility Recall by Central Admixture
Central Admixture Pharmacy Services recalls 10,282 bags of vancomycin in dextrose 5% nationwide after FDA inspection raised sterility assurance concerns for this injectable pharmaceutical product.
Product
vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6075-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0659-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Cardioplegia Solution is recalled due to sterility assurance concerns identified during an FDA inspection. The recall affects 350 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0695-2023·2023-05-31
Neonatal TPN Starter Bags Recalled for Unassured Sterility
Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0425-1.
Category
Drug
Distribution
Distributed nationwide