Hazard

Lack Of Sterility recalls

447 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 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.

376–400 of 447

SevereFDA (Drugs)·D-0402-2022·2022-02-02
Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance
Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.
Product
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0424-2022·2022-02-02
Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0394-2022·2022-02-02
ALUM Concentrate IV Bags Recalled for Lack of Sterility Assurance
Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) IV bags nationwide due to lack of assurance of sterility. The affected product is a prescription intravenous medication supplied in 300 ml bags.
Product
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0399-2022·2022-02-02
Dexamethasone Sodium Phosphate Otic Injection Syringes Recalled for Lack of Sterility Assurance
Edge Pharma LLC is recalling Dexamethasone sodium phosphate sterile otic solution for injection syringes (NDC 05446-0848-01) due to lack of assurance of sterility. Approximately 323 syringes were distributed nationwide.
Product
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0412-2022·2022-02-02
MVASI Sterile Ophthalmic Solution Lacks Assured Sterility
Edge Pharma is recalling MVASI (bevacizumab-awwb) intraocular injection syringes nationwide due to lack of assurance of sterility. The recall affects 199 syringes with code 11-2021-01@2 dated 12/15/2021.
Product
MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2022·2022-02-02
Methotrexate Injection Recalled Due to Lack of Sterility Assurance
Edge Pharma, LLC is recalling Methotrexate, USP, Sterile Solution for Injection (125 mg/5mL) due to lack of assurance of sterility. The recall affects 457 syringes distributed nationwide.
Product
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0370-2022·2022-01-19
Methylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension 400 mg/10mL due to lack of assurance of sterility. The recall affects one lot distributed to facilities in Tennessee, Mississippi, and Ohio.
Product
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0311-2022·2022-01-05
SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.
Product
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0323-2022·2022-01-05
SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance
SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.
Product
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0312-2022·2022-01-05
Midazolam Injection Recalled Due to Lack of Sterility Assurance
SterRx is recalling Midazolam in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The recall affects approximately 36,360 bags distributed across the United States.
Product
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0306-2022·2022-01-05
Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Assurance
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The recall affects 127,260 bags distributed across the U.S.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0310-2022·2022-01-05
Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine injection (8 mg per 250 mL) due to lack of assurance of sterility. The recall affects 5,832 bags distributed nationwide.
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0309-2022·2022-01-05
Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0300-2022·2022-01-05
SterRx Midazolam Injection Recalled for Lack of Sterility Assurance
SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection (50 mg per 50 mL) distributed nationwide due to lack of assurance of sterility. The recall affects 15,660 bags from seven lots manufactured between November and December 2021.
Product
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0315-2022·2022-01-05
dilTIAZem HCl in Dextrose Injection Recalled for Sterility Assurance
SterRx is recalling dilTIAZem HCl in 5% Dextrose Injection due to lack of assurance of sterility. The recall affects 8,946 bags distributed nationwide.
Product
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0322-2022·2022-01-05
Norepinephrine Injection Recalled Due to Lack of Sterility Assurance
SterRx is recalling 36,576 bags of Norepinephrine 16 mg per 250 mL injection (0.9% Sodium Chloride) distributed nationwide because the manufacturer cannot assure the product meets sterility requirements.
Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0261-2022·2021-12-08
Biotin Solution for Injection recalled due to lack of sterility assurance
ASP CARES is recalling Biotin Solution for Injection (10 mg/mL, 30 mL vials) because the manufacturer cannot assure the product's sterility. The affected lot was distributed in the United States.
Product
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0106-2022·2021-11-17
B Complex Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns
Talon Compounding Pharmacy is recalling B Complex Injectable (Lot 07192021:91) due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.
Product
B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0222-2022·2021-11-17
Tri-Mix Injectable Lacks Sterility Assurance, Compounded Medication Recalled
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable medication because the manufacturer cannot guarantee sterility. The affected injectable product was distributed across the United States.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0107-2022·2021-11-17
BI-MIX Papaverine/Phentolamine Injectable Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling BI-MIX Papaverine 40/Phentolamine 2 injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States, Washington D.C., and Puerto Rico.
Product
BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0108-2022·2021-11-17
Compounded Injectable Injection Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Blue Tree Lipo Extreme injectable (with Methylcobalamin) due to lack of assurance of sterility. The product was distributed in the United States.
Product
BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0192-2022·2021-11-17
TRI-MIX Papaverine Injectable from Talon Compounding Pharmacy Recalled
Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 6/ML injectable medication due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Product
TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 6/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0224-2022·2021-11-17
TRI-MIX Injectable Papaverine Phentolamine PGE-1 Lacks Sterility Assurance
Vita Pharmacy (Talon Compounding) is recalling TRI-MIX injectable medication (Lot 07142021:43) distributed across the United States because the manufacturer cannot assure the product meets sterility standards.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0117-2022·2021-11-17
Hydroxocobalamin Injection Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Hydroxocobalamin 1,000 MCG/mL injectable vials due to lack of assurance of sterility. The affected lot was distributed across the United States, including Washington, D.C. and Puerto Rico.
Product
HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0132-2022·2021-11-17
MIC B12 and L-Carnitine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling MIC B12 25/50/50/0.5MG/ML L-Carnitine 250MG/ML Injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.
Product
MIC B12 25/50/50/0.5MG/ML L-CARNITINE 250MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states