Hazard

Sterility Assurance recalls

309 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 sterility assurance 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.

126–150 of 309

HighFDA (Drugs)·D-0719-2023·2023-05-31
Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.
Product
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0615-2023·2023-05-24
Ceftriaxone for Injection Recalled Due to Sterility Assurance Issue
Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.
Product
Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0619-2023·2023-05-24
Injectable Ceftriaxone Recalled for Lack of Sterility Assurance
Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.
Product
Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0617-2023·2023-05-24
Ceftriaxone for Injection Recalled Due to Sterility Assurance Concerns
FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.
Product
Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0611-2023·2023-05-24
Ceftriaxone injection vials recalled for lack of sterility assurance
Astral SteriTech is recalling approximately 66,250 vials of Ceftriaxone for Injection due to lack of sterility assurance. The injectable antibiotic poses a potential contamination risk if used.
Product
Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-211-42
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0612-2023·2023-05-24
Ceftriaxone Injectable Antibiotic Recalled Due to Sterility Assurance Failure
Ceftriaxone for Injection is being recalled due to lack of assurance of sterility. The recall affects 65,950 vials distributed nationwide in the United States.
Product
Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0587-2023·2023-05-24
Ampicillin for Injection Recalled Due to Sterility Assurance Defect
Astral SteriTech Private Ltd. is recalling Ampicillin for Injection due to manufacturing controls that cannot assure product sterility. The FDA Class II recall affects approximately 80,850 vials distributed nationwide.
Product
Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0583-2023·2023-05-24
Ampicillin for injection recalled nationwide due to sterility concerns
Ampicillin for Injection (2g per vial) is being recalled nationwide because the manufacturer cannot assure the product meets sterility standards. All 45,160 affected vials in circulation are included.
Product
Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0595-2023·2023-05-24
Ampicillin and Sulbactam Injection Recalled Due to Sterility Concerns
Astral SteriTech is recalling Ampicillin and Sulbactam for Injection due to inability to assure product sterility. Approximately 357,550 vials distributed nationwide; no illnesses have been reported.
Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0622-2023·2023-05-24
Piperacillin and Tazobactam Injectable Recalled for Sterility Assurance Issue
Astral SteriTech is recalling 204,860 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The FDA classified this as a Class II recall affecting nationwide distribution.
Product
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0632-2023·2023-05-24
PHENYLephrine HCl Injection Recalled for Lack of Sterility Assurance
Apollo Care, LLC is recalling 2,265 syringes of PHENYLephrine HCl Injection (100 mcg/mL) due to lack of assurance of sterility. The affected lots were distributed in Missouri only.
Product
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0644-2023·2023-05-24
Norepinephrine injectable recalled for lack of sterility assurance
Apollo Care is recalling Norepinephrine 4 mg dextrose injection (682 bags) due to lack of assurance of sterility. Distribution was limited to Missouri.
Product
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0609-2023·2023-05-24
Cefepime for Injection recalled due to sterility assurance failure
Astral SteriTech's Cefepime for Injection (1 gram per vial, 550,160 vials nationwide) is being recalled due to lack of assurance of sterility.
Product
Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0647-2023·2023-05-24
Vancomycin IV Injection Recalled for Lack of Sterility Assurance
Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.
Product
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0359-2023·2023-03-08
Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. The recall affects 546,450 vials distributed nationwide.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0307-2023·2023-02-22
FDA recalls Milrinone injectable medication due to lack of sterility assurance
Sentara Infusion Services recalls 83 bags of Milrinone injectable medication nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.
Product
Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG IN
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0277-2023·2023-02-22
Caspofungin Injectable Medication Recalled for Sterility Assurance Issues
Sentara Infusion Services is recalling Caspofungin 50mg injectable bags dispensed nationwide due to lack of sterility assurance. Patients should consult their healthcare provider.
Product
CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2023·2023-02-22
Medline CABG surgical convenience kits recalled due to sterility issue
Medline is recalling 80 units of MEDLINE CABG PACK surgical convenience kits (Lot #22HMH432) nationwide because the perforated bag design cannot maintain sterility of the outer packaging wrapping.
Product
Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0276-2023·2023-02-22
Ampicillin/Sulbactam antibiotic injection recalled due to sterility concerns
Sentara Infusion Services is recalling Ampicillin/Sulbactam 3GM intravenous bags due to lack of sterility assurance. The affected product was dispensed nationwide to home infusion patients.
Product
Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0295-2023·2023-02-22
Hydrocortisone Sterile Injection Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Hydrocortisone sterile injection syringes nationwide due to lack of sterility assurance. Patients who received affected syringes should contact their physician immediately.
Product
HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0230-2023·2023-02-01
Injectable Drug Recalled Due to Sterility Assurance Concerns
An injectable phosphatidylcholine/deoxycholic acid product manufactured by Pharmacy Innovations is being recalled nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.
Product
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0218-2023·2023-02-01
Lidocaine-PF Injectable Vials Recalled for Sterility Assurance Deficiency
Pharmacy Innovations is recalling Lidocaine-PF 5% injectable solution nationwide due to insanitary facility conditions that compromised sterility assurance, discovered during FDA inspection.
Product
LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0221-2023·2023-02-01
Methotrexate Injectable Vials Recalled for Lack of Sterility Assurance
The FDA has recalled Methotrexate intravitreal injectable from Pharmacy Innovations due to lack of assured sterility. An FDA inspection revealed insanitary conditions at the manufacturing facility.
Product
METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0224-2023·2023-02-01
FDA Recalls Mitomycin Ophthalmic Solution for Sterility Assurance Failure
Pharmacy Innovations is recalling Mitomycin ophthalmic solutions nationwide due to a lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
Product
MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0220-2023·2023-02-01
Injectable vitamin formulations recalled due to facility sterility concerns
Pharmacy Innovations is recalling three injectable vitamin formulations due to insanitary facility conditions identified during FDA inspection that may affect product sterility.
Product
METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID 15.625MG/31.25MG/31.25MG/6.25MG/62.5MG/6.25MG/62.5MG/ML
Category
Drug
Distribution
Distributed nationwide