Hazard

Sterility Failure recalls

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

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 462

HighFDA (Drugs)·D-0955-2022·2022-06-08
Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.
Product
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0964-2022·2022-06-08
Oxytocin Injectable Drug Recalled for Lack of Sterility
Nephron Sterile Compounding Center has recalled 3,587 bags of Oxytocin injectable nationwide due to lack of assurance of sterility.
Product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0962-2022·2022-06-08
Lidocaine Injectable Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.
Product
Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0917-2022·2022-06-01
Alpha Lipoic Acid injection vials recalled for sterility assurance defect
Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL due to inability to assure sterility. Patients should contact their healthcare provider to verify their medication and discuss alternatives.
Product
Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0076-30
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-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-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-0936-2022·2022-06-01
Methylcobalamin Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.
Product
Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0941-2022·2022-06-01
FDA Recalls Olympia Mineral Blend Injectable for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls 6,113 vials of Olympia Mineral Blend injectable due to lack of assurance of sterility. The product was distributed nationwide; patients should not use it and should consult their healthcare provider.
Product
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0061-30.
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-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-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-0942-2022·2022-06-01
FDA Recalls Olympia Vita-Complex Injection Due to Sterility Concerns
Olympia Compounding Pharmacy has recalled 8,664 vials of Olympia Vita-Complex B-vitamin injection nationwide due to lack of assurance of sterility. The affected multi-dose vials may pose an infection risk to patients who receive the product.
Product
Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0063-30.
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 (Drugs)·D-0913-2022·2022-06-01
Tri-Immune Boost Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 2,260 vials of Tri-Immune Boost injectable supplement due to lack of sterility assurance. Distribution was nationwide, including Puerto Rico and US Virgin Islands.
Product
Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0104-30
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-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-0926-2022·2022-06-01
Injectable Folic Acid and Hydroxocobalamin Recalled Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 2,441 vials of Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL injectable due to lack of sterility assurance. The affected vials were distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Product
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0112-30
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 (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-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-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-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