Hazard

Sterility recalls

2,419 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,419
Critical: 2
Severe: 2,147
Most recent: 2026-10-14

Of the 2,419 sterility recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,147 (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.

1–25 of 2419

SevereFDA (Drugs)·D-0027-2027·2026-10-14
Carolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 26/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0009-2027·2026-10-14
K.C. Pharmaceuticals Recalls Leader Ultra Lubricating Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling 163,008 cartons of Leader Ultra Lubricating Eye Drops due to a lack of assurance of sterility. The product was distributed nationwide under multiple brand names.
Product
LEADER ULTRA LUBRICATING EYE DROPS — LEADER ULTRA LUBRICATING EYE DROPS (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0024-2027·2026-10-14
FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes because processing equipment used may have compromised the product's sterility.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0026-2027·2026-10-14
Carolina Infusion Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling semaglutide/cyanocobalamin injectable products due to a lack of assurance of sterility related to formulation and processing equipment.
Product
SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0030-2027·2026-10-14
FDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 85/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0036-2027·2026-10-14
Apothecary Pharma Recalls Tirzepatide Injection Vials Due to Sterility Concerns
Apothecary Pharma LLC is recalling 22 vials of Tirzepatide Injection due to a lack of assurance of sterility. The affected product was distributed nationwide.
Product
Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0003-2027·2026-10-14
Good Sense Eye Drops Recalled for Lack of Sterility Assurance
K.C. Pharmaceuticals is recalling Good Sense Eye Drops Irritation Relief and related brands due to a lack of assurance of sterility.
Product
GOODSENSE EYE DROPS IRRITATION RELIEF — GOODSENSE EYE DROPS IRRITATION RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0022-2027·2026-10-14
FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to processing equipment.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0002-2027·2026-10-14
K.C. Pharmaceuticals Recalls Artificial Tears Due to Sterility Concerns
K.C. Pharmaceuticals is recalling 505,896 cartons of artificial tears sold under multiple brands because the product lacks assurance of sterility.
Product
LEADER ARTIFICIAL TEARS 15 ML — LEADER ARTIFICIAL TEARS 15 ML (POLYVINYL ALCOHOL, POVIDONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0020-2027·2026-10-14
Carolina Infusion Recalls Sermorelin Acetate Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Sermorelin Acetate 1 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0028-2027·2026-10-14
Carolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling specific lots of Tirzepatide/Cyanocobalamin 64/2 mg/mL injectable because the product may lack assurance of sterility.
Product
TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0018-2027·2026-10-14
Carolina Infusion Recalls Semaglutide Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Semaglutide 3 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0019-2027·2026-10-14
FDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling semaglutide/cyanocobalamin injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0017-2027·2026-10-14
FDA Recalls Tirzepatide Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide 26 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0025-2027·2026-10-14
FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes because processing equipment used in compounding raised concerns about the product's sterility.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0007-2027·2026-10-14
K.C. Pharmaceuticals Recalls Good Sense Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling Good Sense Eye Drops Original Formula due to a lack of assurance of sterility. The recall affects 1,025,448 cartons distributed nationwide.
Product
GOODSENSE EYE DROPS ORIGINAL FORMULA — GOODSENSE EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0032-2027·2026-10-14
FDA Recalls Tri-MIX Syringes Due to Sterility Assurance Concerns
Carolina Infusion, LLC is recalling Tri-MIX compounded syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0004-2027·2026-10-14
K.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling Leader Advanced Relief Eye Drops and related brands due to a lack of assurance of sterility. The recall covers 208,896 cartons distributed nationwide.
Product
LEADER ADVANCED RELIEF EYE DROPS — LEADER ADVANCED RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0037-2027·2026-10-14
Apothecary NAD+ Injection Recalled for Lack of Sterility Assurance
Apothecary Pharma is recalling NAD+ Injection vials due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0029-2027·2026-10-14
FDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 76/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0005-2027·2026-10-14
K.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling multiple brands of eye drops due to a lack of assurance of sterility. The recall covers 1,435,830 cartons distributed nationwide.
Product
TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE — TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0023-2027·2026-10-14
FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to processing equipment.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0031-2027·2026-10-14
Carolina Infusion Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0021-2027·2026-10-14
FDA recalls injectable compounded mixture in single-use syringes
Carolina Infusion LLC is recalling QUAD-MIX injectable compounded product nationwide due to sterility concerns.
Product
QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0874-2026·2026-10-07
Aurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
Aurolab Trust is recalling FOCUS PI eye drops because the agency could not verify the product's sterility. Consumers in Virginia should stop using the product.
Product
FOCUS PI — FOCUS PI (HYPROMELLOSE EYE DROPS 0.7%)
Category
Drug
Distribution
1 state