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.

1051–1075 of 1417

SevereFDA (Drugs)·D-0013-2017·2016-10-19
Leiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns
Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a lack of assurance of sterility.
Product
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, C
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0011-2017·2016-10-19
Leiter's Compounding Recalls Brilliant Blue G Injection Due to Sterility Concerns
Leiter's Compounding is recalling Brilliant Blue G injections because they were produced using recalled filters, raising concerns about sterility.
Product
Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0004-2017·2016-10-12
The Apothecary Shoppe Recalls Tri-Mix 18/1/10 Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling Tri-Mix 18/1/10 vials because the medication was sterilized using a recalled filter, raising concerns about sterility assurance.
Product
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1536-2016·2016-10-05
Vital Care Compounder Recalls Trypan Blue Vials Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 62 vials of Trypan Blue 0.3% due to a lack of assurance of sterility.
Product
Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1540-2016·2016-10-05
FDA Recalls Methylcobalamin Vials Due to Lack of Sterility Assurance
Pharmacy Plus, Inc. is recalling Methylcobalamin 5,000mcg/ml vials due to lack of assurance of sterility. The recall affects 36 vials distributed in Mississippi.
Product
Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1534-2016·2016-10-05
Vital Care Compounder Recalls Papaverine and Phentolamine Vials Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine 150 mg / Phentolamine 5 mg vials due to a lack of assurance of sterility.
Product
Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1543-2016·2016-10-05
FDA Recalls Pre-Op Pledget Soln + Tetracaine Due to Sterility Concerns
Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln + Tetracaine vials because the agency cannot ensure the product is sterile.
Product
Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1537-2016·2016-10-05
Vital Care Compounder Recalls Brilliant Blue G Vials Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 14 vials of Brilliant Blue G 0.025% due to a lack of assurance of sterility.
Product
Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1545-2016·2016-10-05
FDA Recalls Vital Care Compounder Injection Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/ATROP 150/5/5 injection vials due to a lack of assurance of sterility.
Product
C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1533-2016·2016-10-05
FDA Recalls Vital Care Compounder Eye Drops for Sterility Concerns
The FDA is recalling specific lots of MOXI/DEX/KETOROLAC eye drops from Vital Care Compounder due to a lack of assurance of sterility.
Product
MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1531-2016·2016-10-05
Vital Care Compounder Recalls Apomorphine HCl Injection Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Apomorphine HCl 3mg/ml Sterile Injection Solution due to a lack of assurance of sterility.
Product
Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1463-2016·2016-08-31
Talon Compounding Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
Talon Compounding Pharmacy is recalling Sermorelin and Sermorelin/GHRP-2 injections because the FDA cannot assure the products are sterile.
Product
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1447-2016·2016-08-03
Medicap Pharmacy Recalls Acetylcyst 10% Ophthalmic Solution for Sterility Concerns
Medicap Pharmacy is recalling Acetylcyst 10% Ophthalmic Solution because sterile products were not produced in a controlled, sterile environment.
Product
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1302-2016·2016-07-20
Pharmakon Recalls Magnesium Sulfate Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 bags of Magnesium Sulfate 1GM in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1175-2016·2016-07-20
Medaus Recalls B-Complex and Lidocaine Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of B-Complex with Methyl B12 and Lidocaine vials because the company cannot guarantee the product is sterile.
Product
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1315-2016·2016-07-20
Pharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 215 bags of Morphine Sulfate in Dextrose due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.
Product
Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1281-2016·2016-07-20
Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 25 units of Morphine Sulfate syringes because the company cannot guarantee the products are sterile.
Product
Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1183-2016·2016-07-20
Medaus Recalls Estradiolval and Testosterone Vials Due to Sterility Concerns
Medaus, Inc. is recalling Estradiolval and testosterone vials because the company cannot ensure the product is sterile.
Product
ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1322-2016·2016-07-20
Pharmakon Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,175 units of Succinylcholine Chloride 20 mg/mL syringes due to a lack of assurance of sterility.
Product
Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1218-2016·2016-07-20
Medaus Recalls Methyl B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Methyl B12 5mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Product
METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1275-2016·2016-07-20
Pharmakon Recalls Promethazine IV Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 725 units of compounded Promethazine IV bags due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Promethazine 12.5mg 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 45183-0186-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1264-2016·2016-07-20
Pharmakon Recalls Propofol Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,580 units of compounded Propofol 1% injection because the company cannot ensure the product is sterile.
Product
Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1332-2016·2016-07-20
Pharmakon Recalls Lidocaine Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling 50 vials of Lidocaine 2% syringes because the company cannot ensure the products are sterile.
Product
Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1226-2016·2016-07-20
Medaus Recalls Minoxidil Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling specific lots of Minoxidil 0.5% vials because the company cannot ensure the product is sterile.
Product
MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1280-2016·2016-07-20
Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 18 units of Cefazolin 3GM in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.
Product
Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48
Category
Drug
Distribution
Distributed nationwide