Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,384
Critical: 1
Severe: 2,114
Most recent: 2026-09-09

Of the 2,384 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,114 (89%) 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 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.

1151–1175 of 2384

SevereFDA (Drugs)·D-1288-2016·2016-07-20
Pharmakon Recalls Bupivacaine HCI Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 40 units of Bupivacaine HCI 0.125% syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1309-2016·2016-07-20
Pharmakon Recalls Diltiazem HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 bags of Diltiazem HCI 250 mg in 5% Dextrose due to a lack of assurance of sterility.
Product
Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1277-2016·2016-07-20
Pharmakon Recalls Phenylephrine HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Phenylephrine HCI 40mg/250 mL bags because the company cannot ensure the products are sterile.
Product
Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1202-2016·2016-07-20
Medaus Recalls Lipo #4 Vials Due to Sterility Concerns
Medaus, Inc. is recalling Lipo #4 vials because the FDA cannot assure the product is sterile. The recall affects vials distributed in the U.S., Japan, and New Zealand.
Product
LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1286-2016·2016-07-20
Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 syringes of Fentanyl Citrate 25 mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.
Product
Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1227-2016·2016-07-20
Medaus Recalls Molybdenum Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Molybdenum 250mcg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.
Product
MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1167-2016·2016-07-20
Medaus Recalls B-Complex #3 Vials Due to Sterility Concerns
Medaus, Inc. is recalling B-Complex #3 vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1303-2016·2016-07-20
Pharmakon Recalls Norepinephrine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 70 bags of Norepinephrine Bitartrate 8mg in 5% Dextrose due to a lack of assurance of sterility.
Product
Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1276-2016·2016-07-20
Pharmakon Recalls Promethazine Compounded Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 485 units of compounded Promethazine 25 mg in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.
Product
Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0187-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1341-2016·2016-07-20
Pharmakon Recalls Midazolam HCl Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 bags of Midazolam HCl 1mg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1292-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 units of compounded Hydromorphone HCI syringes due to a lack of assurance of sterility.
Product
Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1344-2016·2016-07-20
Pharmakon Recalls Sufentanil and Bupivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 595 bags of compounded Sufentanil and Bupivacaine due to a lack of assurance of sterility.
Product
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1298-2016·2016-07-20
Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 468 units of compounded Oxytocin 30 Units in Lactated Ringers due to a lack of assurance of sterility.
Product
Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0766-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1297-2016·2016-07-20
Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 72 units of compounded Oxytocin 10 Units in Lactated Ringers due to a lack of assurance of sterility.
Product
Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1329-2016·2016-07-20
Pharmakon Recalls Ketamine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 150 units of compounded Ketamine 2 mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0938-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1177-2016·2016-07-20
Medaus Recalls Cesium Chloride Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Cesium Chloride 600mg/mL vials because the company cannot assure the sterility of the product.
Product
CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1192-2016·2016-07-20
Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Hydroxy B12 1000mcg/mL vials because the company cannot ensure the product is sterile.
Product
HYDROXY B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1170-2016·2016-07-20
Medaus Recalls B-Complex Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of B-Complex Without B12 vials because the company cannot assure the sterility of the product.
Product
B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1278-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 4,500 units of Hydromorphone 1mg/mL syringes due to a lack of assurance of sterility.
Product
HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1168-2016·2016-07-20
Medaus Recalls B-Complex #3 Vials Due to Sterility Concerns
Medaus, Inc. is recalling B-Complex #3 vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.
Product
B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1235-2016·2016-07-20
Medaus Recalls Pyridoxine HCL Vials Due to Sterility Concerns
Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot assure the sterility of the product.
Product
PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1206-2016·2016-07-20
Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns
Medaus, Inc. is recalling Lipo-Injection vials containing methyl B12 and other vitamins due to a lack of assurance of sterility.
Product
LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1300-2016·2016-07-20
Pharmakon Recalls Midazolam HCI Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 45 bags of compounded Midazolam HCI due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1234-2016·2016-07-20
Medaus Recalls Pyridoxal and Thiamine Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific vials of Pyridoxal/Thiamine/Lidocaine due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.
Product
PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1314-2016·2016-07-20
Pharmakon Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 75 bags of Fentanyl Citrate injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Product
Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48
Category
Drug
Distribution
Distributed nationwide