Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,691
Critical: 12
Severe: 931
Most recent: 2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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 1691

HighFDA (Drugs)·D-0932-2022·2022-06-01
Lipo-Mino-Mix Injectable Compounded Drug Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Lipo-Mino-Mix injectable vitamins nationwide due to manufacturing failure to ensure product sterility. No illnesses have been reported.
Product
Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only, Olymp
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0945-2022·2022-06-01
FDA Recalls Phenylephrine 1 mg/mL Vials for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 9,102 vials of Phenylephrine 1 mg/mL due to lack of assurance of sterility. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
Product
Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0923-2022·2022-06-01
Pyridoxine Injection Vials Recalled by FDA Due to Sterility Failure
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine 100 mg/mL injectable due to lack of assurance of sterility. The multi-dose vials were distributed nationwide and may pose infection risk if administered.
Product
Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0066-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0906-2022·2022-06-01
FDA Recalls Sodium Tetradecyl Sulfate Injection Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 0.3% Injection due to lack of sterilization assurance. The 943 vials of this injectable product were distributed nationwide and may not meet sterile manufacturing requirements.
Product
Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0907-2022·2022-06-01
FDA Recalls Sodium Tetradecyl Sulfate Injectable Over Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 1.5% Injection (480 vials, Lot B24308-22) due to lack of assurance of sterility. The injectable was distributed nationwide.
Product
Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0931-2022·2022-06-01
Lidocaine-Epinephrine Injectable Vials Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000 injection vials due to lack of sterility assurance. The recall affects 310 vials distributed nationwide.
Product
Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0099-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0912-2022·2022-06-01
FDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalled Testosterone Cypionate injection vials due to lack of sterility assurance. The affected lot was distributed nationwide. Patients should contact their healthcare provider immediately.
Product
Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0924-2022·2022-06-01
Dexpanthenol 250 mg/mL Injectable Solution Recalled for Sterility Failure
Olympia Compounding Pharmacy is recalling 1,296 vials of Dexpanthenol 250 mg/mL injectable solution distributed nationwide due to lack of assurance of sterility in the manufacturing process.
Product
Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0070-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0943-2022·2022-06-01
Ondansetron Hydrochloride vials recalled due to sterility assurance concerns
Olympia Compounding Pharmacy recalls 911 vials of Ondansetron Hydrochloride (1 mg/mL) due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0127-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0927-2022·2022-06-01
Compounded Injectable Formula F1 Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling Formula F1, a compounded injectable medication, due to lack of sterility assurance. The 1,703 vials were distributed nationwide.
Product
Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0898-2022·2022-04-13
Medline Excelsior Medical Sterile Saline Flush Syringes Recalled for Sterility Failure
Medline Industries is recalling 7,800 Excelsior Medical 10mL Sterile Field Saline Flush syringes due to sterility failure of the exterior syringe surface, which may prevent the product from being safely used on a sterile field.
Product
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0741-2022·2022-04-13
Tetracaine Injection Recalled for Sterility Assurance Manufacturing Defect
Tetracaine 1% Injectable is being recalled due to sterility assurance failures caused by manufacturing deviations that may compromise product sterility.
Product
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0663-2022·2022-03-23
Morphine Sulfate Infusion Recall Due to Sterility Assurance Failure
Family Pharmacy of Statesville is recalling Morphine Sulfate 6 mg/mL infusions in 250 mL bags due to lack of assurance of sterility. The affected product was distributed in North Carolina.
Product
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0662-2022·2022-03-23
Vancomycin Ophthalmic Solution Recalled Due to Sterility Concerns
Family Pharmacy of Statesville is recalling Vancomycin 14 mg/mL Fortified Ophthalmic Solution due to lack of assurance of sterility. The affected lot was distributed in North Carolina.
Product
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0667-2022·2022-03-23
Fentanyl Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling one lot of Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure the product's sterility.
Product
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0664-2022·2022-03-23
Ketamine 50 mg Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling three bags of Ketamine 50 mg Infusion Solution because the manufacturer cannot assure sterility of the product.
Product
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0561-2022·2022-02-16
Gentueri Viral Transport Medium Kit recalled due to sterility failure
Gentueri Inc is recalling Viral Transport Medium Kits due to failed sterility testing and evidence of contamination. The recall affects 13,975 units distributed to Illinois, Nebraska, and Wisconsin.
Product
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Category
Medical Device
Distribution
3 states
SevereFDA (Drugs)·D-0413-2022·2022-02-02
Phenol Injection Solution Recall Due to Lack of Sterility Assurance
Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.
Product
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0404-2022·2022-02-02
Lidocaine HCL / Bupivacaine HCL Sterile Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 syringes distributed nationwide.
Product
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0414-2022·2022-02-02
Eye Drops Recalled for Lack of Sterility Assurance by Edge Pharma
Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured sterility. The product is used for topical eye application.
Product
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0403-2022·2022-02-02
Gemcitabine Intravesical Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling approximately 627 syringes of Gemcitabine Sterile Intravesical Solution nationwide because the manufacturer cannot guarantee the product is sterile. The recalled batches were distributed between December 2021 and February 2022.
Product
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0369-2022·2022-01-19
Exela Sodium Bicarbonate Injection Recalled for Sterility Assurance Failure
Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The affected lot (C0001088/P0001317, expiring 08/2023) was distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0313-2022·2022-01-05
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 40 bags of Morphine Sulfate in 5% Dextrose Injection (1 mg per mL) distributed nationwide due to lack of assurance of sterility. The product is subject to contamination risk.
Product
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0302-2022·2022-01-05
dilTIAZem HCl Injection Recalled Due to Sterility Assurance Failure
SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.
Product
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0321-2022·2022-01-05
SterRx Norepinephrine 8 mg Sodium Chloride Injection Recalled
SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Product
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
Category
Drug
Distribution
Distributed nationwide