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.

376–400 of 663

HighFDA (Devices)·Z-0195-2023·2022-11-16
Sterile Medical Extension Sets Distributed Without Expiration Dates
Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.
Product
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessor
Category
Medical Device
Distribution
11 states
HighFDA (Drugs)·D-0026-2023·2022-11-09
Acetylcysteine eye drops recalled for sterility assurance defect
Pharmacy Plus Inc. is recalling acetylcysteine 10% eye drop solution due to manufacturing issues that cannot guarantee sterility. Lot 66895 was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0040-2023·2022-11-09
Moxifloxacin Preservative-Free Eye Drops Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling Moxifloxacin 0.15 mg/0.1 mL preservative-free eye drops in 1 mL syringes due to lack of assured sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.
Product
MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0036-2023·2022-11-09
Lidocaine-Epinephrine Injectable Solution Recalled for Sterility Assurance Issues
Vital Care Compounder is recalling 7 syringes of Lidocaine-Epinephrine solution due to lack of sterility assurance. FDA inspection found the products cannot be guaranteed to be sterile.
Product
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0045-2023·2022-11-09
Injectable Drug Recalled Over Failure to Assure Product Sterility
Vital Care Compounder is recalling a compounded injectable medication due to FDA findings that the manufacturing process failed to guarantee sterility. Two lots were distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0032-2023·2022-11-09
Cyclosporin 0.07% Ophthalmic Solution Recalled Due to Sterility Concerns
Pharmacy Plus recalls 67 bottles of Cyclosporin 0.07% ophthalmic solution across four states due to manufacturing process that cannot guarantee sterility.
Product
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0044-2023·2022-11-09
Compounded Injectable Drug Recalled Due to Sterility Assurance Defect
A compounded injectable medication containing papaverine, phentolamine, and prostaglandin was recalled after FDA inspection found it was not produced under conditions that guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-1516-2022·2022-09-21
MIC/B12 Injectable Vials Recalled for Lack of Sterility Assurance
Carolina Infusion is recalling MIC/B12 injectable vials due to lack of assurance of sterility. Affected lots were distributed nationwide.
Product
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1277-2022·2022-07-27
Rocuronium Bromide Pre-Filled Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection syringes nationwide due to lack of assurance of sterility. Approximately 6,340 syringes from lot RC2003B (expiration August 28, 2022) are affected.
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1266-2022·2022-07-27
Morphine Sulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 8,985 syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1246-2022·2022-07-27
Atropine Sulfate Injection Recalled Nationwide for Sterility Assurance Failure
Nephron Sterile Compounding Center LLC is recalling Atropine Sulfate Injection pre-filled syringes nationwide due to lack of assurance of sterility affecting approximately 13,340 syringes.
Product
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1269-2022·2022-07-27
FDA Recalls Nephron Cardioplegia Solution Over Sterility Assurance Concerns
Nephron Sterile Compounding Center is recalling del Nido Cardioplegia Solution due to lack of assurance of sterility. The 1765 bags affected were distributed nationwide.
Product
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1261-2022·2022-07-27
Ketamine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling 47,905 pre-filled syringes of Ketamine HCl Injection nationwide due to lack of sterility assurance. Users should contact the manufacturer for handling instructions.
Product
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-511-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1202-2022·2022-07-20
Folic Acid Injectable Vials Recalled Due to Sterility Concerns
TMC Acquisition LLC is recalling Folic Acid 5mg/mL injectable vials due to lack of assurance of sterility. The recall affects 45 units distributed nationwide and in Puerto Rico.
Product
Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1223-2022·2022-07-20
PT-141 10mg/mL Injectable Vials Recalled for Sterility Assurance Concerns
Tailor Made Compounding is recalling PT-141 10mg/mL vials nationwide due to inability to assure sterility. The recall affects 392 vials in 1mL and 2mL sizes distributed in 2022.
Product
PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1222-2022·2022-07-20
Procaine HCL Injectable Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.
Product
Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1201-2022·2022-07-20
Estradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
Tailor Made Compounding recalls 349 vials of Estradiol Cypionate 10mg/mL due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Product
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1213-2022·2022-07-20
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling 924 vials of Methionine/Inositol/Choline B12 + Carnitine injectable compound nationwide due to lack of assurance of sterility.
Product
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1231-2022·2022-07-20
Testosterone Cypionate Injections Recalled for Sterility Assurance Failure
Tailor Made Compounding recalls Testosterone Cypionate injections due to lack of sterility assurance. The recall affects 4,219 vials distributed nationwide.
Product
Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1236-2022·2022-07-20
Compounded Testosterone Injection Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding is recalling 176 vials of testosterone cypionate/propionate injectable due to lack of assurance of sterility. The product was distributed nationwide.
Product
Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1212-2022·2022-07-20
Melanotan I Injectable Vials Recalled Due to Lack of Sterility Assurance
Tailor Made Compounding has recalled 182 vials of Melanotan I injectable due to lack of assurance of sterility. The affected vials were distributed nationwide and in Puerto Rico.
Product
Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1229-2022·2022-07-20
Teriparatide Injectable Syringes Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling Teriparatide injectable syringes nationwide due to lack of assurance of sterility. Patients using affected batches should contact their healthcare provider immediately.
Product
Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1243-2022·2022-07-20
Glutathione Injectable Vials Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling Glutathione 200mg/ml injectable vials due to lack of assurance of sterility. The recall affects 485 vials distributed nationwide in the USA and Puerto Rico.
Product
Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1230-2022·2022-07-20
Testosterone Cypionate Injectable Vials Recalled Due to Sterility Assurance Concerns
TMC Acquisition LLC is recalling Testosterone Cypionate injectable vials (100mg/ml) due to lack of assurance of sterility. The recall affects 273 vials distributed nationwide in the USA and Puerto Rico.
Product
Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1209-2022·2022-07-20
Hydroxocobalamin Injection Recalled for Lack of Sterility Assurance
TMC Acquisition LLC is recalling specific batches of Hydroxocobalamin Preservative Free injectable due to lack of sterility assurance. The affected vials were distributed nationwide in the USA and Puerto Rico.
Product
Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide