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.

926–950 of 1417

SevereFDA (Drugs)·D-0322-2018·2018-02-14
FDA Recalls Sterile Morphine Sulfate Preparations Due to Sterility Concerns
Intrathecal Compounding Specialist, LLC is recalling sterile morphine sulfate preparations compounded between October 16 and November 17, 2017, due to a lack of sterility assurance.
Product
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0321-2018·2018-02-14
FDA Recalls Hydromorphone Sterile Drug Preparations for Lack of Sterility Assurance
Intrathecal Compounding Specialist is recalling sterile drug preparations made from Hydromorphone Base Solution due to a lack of sterility assurance.
Product
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0323-2018·2018-02-14
FDA Recalls Sufentanil Citrate Preparations Due to Sterility Concerns
The FDA is recalling sterile drug preparations made from Sufentanil Citrate Base Solution due to a lack of sterility assurance. The products were compounded by Intrathecal Compounding Specialists.
Product
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0320-2018·2018-02-14
FDA Recalls Fentanyl Citrate Sterile Drug Preparations for Sterility Concerns
Intrathecal Compounding Specialist, LLC is recalling sterile drug preparations made from Fentanyl Citrate Base Solution due to a lack of sterility assurance.
Product
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0138-2018·2018-01-03
SSM St. Clare Recalls Compounded Fentanyl and Ropivacaine Injectable Bags
SSM St. Clare Health Center is recalling compounded fentanyl and ropivacaine injectable bags due to a lack of sterility assurance. Microbial growth was detected during a routine simulation, though no distributed product was found to contain microorganisms.
Product
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0011-2018·2017-10-25
Symbio Muc Eye Recalled Due to Lack of Sterility Assurance
Deserving Health International Corp is recalling Symbio Muc Eye eye drops because the product lacks assurance of sterility. The affected units were distributed throughout the United States.
Product
Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337. NDC 69711-125-61
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1154-2017·2017-09-20
Bella Pharmaceuticals Recalls L-Glutamine Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling specific lots of L-Glutamine 100mg vials because the company cannot guarantee the product is sterile.
Product
L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1148-2017·2017-09-20
Bella Pharmaceuticals Recalls Mannitol 20% Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling Mannitol 20% 10 mL vials because the company cannot ensure the product is sterile.
Product
Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1151-2017·2017-09-20
Bella Pharmaceuticals Recalls B-Complex Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling 45 vials of B-Complex due to a lack of assurance of sterility. The affected lot is BPBC3080517, expiring 2/5/18.
Product
B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1150-2017·2017-09-20
Bella Pharmaceuticals Recalls Calcium Chloride Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling specific lots of Calcium chloride 10% vials because the company cannot ensure the product is sterile.
Product
Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1158-2017·2017-09-20
Bella Pharmaceuticals Recalls Sodium Bicarbonate Vials Due to Sterility Concerns
Bella Pharmaceuticals is recalling specific lots of Sodium Bicarbonate 8.4% vials because the company cannot ensure the product is sterile.
Product
Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1070-2017·2017-08-16
Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 8,928 bags of Norepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL due to a lack of sterility assurance.
Product
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1079-2017·2017-08-16
Cantrell Drug Company Recalls Rocuronium Bromide Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Rocuronium Bromide Injection Solution due to a lack of sterility assurance. The affected syringes were distributed nationwide in the US.
Product
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1078-2017·2017-08-16
Cantrell Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns
Cantrell Drug Company is recalling Neostigmine Methylsulfate Injection Solution due to a lack of sterility assurance. The affected syringes were distributed nationwide.
Product
Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1063-2017·2017-08-16
Cantrell Drug Company Recalls Ephedrine Sulfate Injection Syringes
Cantrell Drug Company is recalling 7,656 syringes of Ephedrine Sulfate Injection Solution due to a lack of sterility assurance. The affected products were distributed nationwide.
Product
Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1074-2017·2017-08-16
Cantrell Drug Recalls Phenylephrine Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Phenylephrine HCL syringes because they may lack sterility assurance. The affected products were distributed nationwide.
Product
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1065-2017·2017-08-16
Cantrell Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling 75,840 syringes of Glycopyrrolate Injection Solution nationwide because of a lack of sterility assurance.
Product
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1067-2017·2017-08-16
Cantrell Drug Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Glycopyrrolate Injection Solution due to a lack of sterility assurance. The affected syringes were distributed nationwide.
Product
Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1068-2017·2017-08-16
Cantrell Drug Recalls Succinylcholine Chloride Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride Injection Solution due to a lack of sterility assurance.
Product
Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1076-2017·2017-08-16
Cantrell Drug Recalls Adenosine Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling Adenosine in 0.9% Sodium Chloride syringes due to a lack of sterility assurance.
Product
Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1075-2017·2017-08-16
Cantrell Drug Recalls Sodium Bicarbonate Injection Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Sodium Bicarbonate 8.4% Injection Solution because of a lack of sterility assurance.
Product
Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1066-2017·2017-08-16
Cantrell Recalls Glycopyrrolate Injection Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling 21,080 syringes of Glycopyrrolate Injection Solution due to a lack of sterility assurance.
Product
Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1072-2017·2017-08-16
Cantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns
Cantrell Drug Company is recalling 3,039 bags of Norepinephrine Bitartrate 4 mg in 0.9% Sodium Chloride due to a lack of sterility assurance.
Product
Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1064-2017·2017-08-16
Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling Ephedrine Sulfate syringes due to a lack of sterility assurance. The recall covers 49,666 syringes distributed nationwide.
Product
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1073-2017·2017-08-16
Cantrell Drug Recalls Diltiazem HCl Bags Due to Sterility Concerns
Cantrell Drug Company is recalling Diltiazem HCl 125 mg in 5% Dextrose single-dose bags because of a lack of sterility assurance. The recall covers 2,761 bags distributed nationwide.
Product
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
Category
Drug
Distribution
Distributed nationwide