Hazard

Lack Of Sterility recalls

1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,417
Critical: 3
Severe: 1,048
Most recent: 2026-07-29

Of the 1,417 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,048 (74%) 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 lack of sterility 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.

326–350 of 1417

HighFDA (Drugs)·D-0968-2022·2022-06-08
Rocuronium Bromide Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection pre-filled syringes nationwide due to lack of sterility assurance. Approximately 604,080 syringes are affected.
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 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: 69374-924-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0969-2022·2022-06-08
Succinylcholine Chloride Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.
Product
Succinylcholine Chloride Injection, USP, 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: 69374-920-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0967-2022·2022-06-08
Phenylephrine HCl Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0957-2022·2022-06-08
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.
Product
Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0916-2022·2022-06-01
FDA Recalls Zinc Chloride Injectable Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 1,291 vials of Zinc Chloride injectable nationwide due to lack of assurance of sterility.
Product
Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0071-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0928-2022·2022-06-01
Formula F2 Compounded Injectable Medication Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Formula F2, a multi-ingredient injectable medication, because the manufacturer cannot assure sterility. The recall affects 72 vials distributed nationwide.
Product
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0002-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0929-2022·2022-06-01
Compounded Injectable Medication Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling 205 vials of Formula F9 injectable medication nationwide due to lack of assurance of sterility. The FDA has classified this as a Class II recall.
Product
Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0948-2022·2022-06-01
Compounded injectable medication recalled for sterility assurance failure
Olympia Compounding Pharmacy is recalling QM-3, a multi-dose compounded injectable, due to lack of sterility assurance. The recall includes 414 vials distributed nationwide.
Product
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0019-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0899-2022·2022-06-01
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Olympia Compounding Pharmacy recalled 1,710 vials of RE-2 injectable medication due to lack of assurance of sterility. Affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Product
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0930-2022·2022-06-01
Lidocaine 2% injectable solution recalled for lack of sterility assurance
Olympia Pharmaceuticals recalled 1195 vials of Lidocaine 2% due to lack of assurance of sterility. The vials were distributed nationwide and should not be used.
Product
Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0946-2022·2022-06-01
Pyridoxine Injection Vials Recalled Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine HCL 100 mg/mL injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Pyridoxine HCL 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-0935-2022·2022-06-01
Magnesium Chloride injection recalled due to lack of sterility assurance
Olympia Compounding Pharmacy is recalling 1,597 vials of Magnesium Chloride injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
Product
Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0072-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0934-2022·2022-06-01
Injectable drug recalled for lack of sterility assurance
Olympia Compounding Pharmacy is recalling injectable Lipostat Plus SF vials due to inability to assure sterility. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0048-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0911-2022·2022-06-01
Testosterone Cypionate Injectable Vials Recalled Due to Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls Testosterone Cypionate injectable vials distributed nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.
Product
Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0054-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0777-2022·2022-04-27
Ipamorelin and Sermorelin Injectable Medications Recalled Due to Sterility Deviations
North American Custom Laboratories is recalling 189 vials of Ipamorelin/Sermorelin injectable due to manufacturing deviations that call into question the sterility of this prescription medication.
Product
Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0780-2022·2022-04-27
PT-141 Injection Recalled for Sterility Assurance Defect
PT-141 (Bremelanotide) injection vials are recalled due to manufacturing deviations that compromise sterility assurance. The FDA Class II recall involves 43 vials distributed nationwide.
Product
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0743-2022·2022-04-13
Phenobarbital Sodium Injection Recalled for Sterility Assurance Deviations
Vitae Enim Vitae Scientific is recalling Phenobarbital Sodium Injection nationally due to deviations from manufacturing practices that compromise sterility assurance on this injectable drug.
Product
PHENOBARBITAL SODIUM — PHENOBARBITAL SODIUM (PHENOBARBITAL SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0734-2022·2022-04-06
Testosterone Cypionate Injectable Vials Recalled for Lack of Sterility Assurance
Drug Depot, Inc. is recalling 24 vials of Testosterone Cypionate 200 MG/ML Injectable nationwide due to lack of sterility assurance. The product was distributed throughout the USA and Puerto Rico.
Product
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0728-2022·2022-04-06
FDA Recalls Gonadorelin Injectable Vials for Lack of Sterility Assurance
Drug Depot, Inc. is recalling Gonadorelin 0.2 mg/mL injectable vials distributed nationwide due to lack of sterility assurance. Approximately 6,017 vials are affected.
Product
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0729-2022·2022-04-06
Gonadorelin injectable recalled for lack of sterility assurance
Drug Depot recalls 1,843 vials of Gonadorelin injectable nationwide due to lack of sterility assurance. Patients should consult their healthcare provider regarding previously dispensed doses.
Product
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0732-2022·2022-04-06
Testosterone Cypionate Injectable Recalled Due to Lack of Sterility Assurance
Drug Depot, Inc. is recalling 620 vials of Testosterone Cypionate/DHEA injectables due to lack of sterility assurance in manufacturing. The product was distributed nationwide.
Product
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0730-2022·2022-04-06
Injectable testosterone-anastrozole mixture recalled for sterility assurance failure
Drug Depot (APS Pharmacy) is recalling testosterone cypionate/anastrozole injectable oil due to lack of sterility assurance. The recall affects 846 vials distributed nationwide.
Product
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0735-2022·2022-04-06
Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Drug Depot recalled 17 vials of Testosterone Cypionate Injectable due to lack of sterility assurance in manufacturing. The recalled product was distributed nationwide and should not be used.
Product
TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0665-2022·2022-03-23
Lorazepam 1 mg/mL Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Lorazepam 1 mg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure sterility of the product.
Product
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0661-2022·2022-03-23
Trimix Injectable Vials Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Trimix (Alprostadil/Papaverine/Phentolamine) injectable vials distributed in North Carolina due to lack of assurance of sterility.
Product
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state