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.

951–975 of 1417

SevereFDA (Drugs)·D-1061-2017·2017-08-16
Cantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling specific lots of Ephedrine Sulfate syringes due to a lack of sterility assurance. The affected products were distributed nationwide.
Product
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1046-2017·2017-08-09
Hospira Recalls Potassium Phosphates Injection Due to Sterility Concerns
Hospira is recalling 20.3 million vials of Potassium Phosphates Injection because of a lack of sterility assurance. The product was distributed in the U.S. and several international locations.
Product
Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1047-2017·2017-08-09
Hospira Recalls 8.4% Sodium Bicarbonate Injection Due to Sterility Concerns
Hospira is recalling 8.4% Sodium Bicarbonate Injection vials because they may lack sterility assurance. The recall covers 91,483,150 vials distributed in the U.S. and internationally.
Product
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1048-2017·2017-08-09
Hospira Recalls Quelicin Injection Due to Lack of Sterility Assurance
Hospira is recalling Quelicin (succinylcholine chloride) injection vials because they may lack sterility assurance. The recall covers 15,034,600 vials distributed in the U.S. and internationally.
Product
QUELICIN — QUELICIN (SUCCINYLCHOLINE CHLORIDE)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1049-2017·2017-08-09
Hospira Recalls Sodium Bicarbonate Additive Solution Due to Sterility Concerns
Hospira is recalling specific lots of Sodium Bicarbonate 4% Additive Solution because they may lack sterility assurance. The recall covers 21.4 million vials distributed in the U.S. and internationally.
Product
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1011-2017·2017-08-02
SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags for Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.
Product
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1005-2017·2017-08-02
SCA Pharmaceuticals Recalls Bupivacaine HCl Due to Sterility Concerns
SCA Pharmaceuticals is recalling Bupivacaine HCl 0.1% bags due to a lack of assurance of sterility and potential for leaking.
Product
BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1027-2017·2017-08-02
SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
Product
PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1024-2017·2017-08-02
SCA Pharmaceuticals Recalls Phenylephrine HCl Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Phenylephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
Product
PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1028-2017·2017-08-02
SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Phenylephrine 100 mg injection bags because they lack assurance of sterility and may leak.
Product
PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1009-2017·2017-08-02
SCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of fentanyl citrate injection bags due to a lack of assurance of sterility and potential for leaking.
Product
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1021-2017·2017-08-02
SCA Pharmaceuticals Recalls Epinephrine Bitartrate Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Epinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
Product
NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1004-2017·2017-08-02
SCA Pharmaceuticals Recalls Phenylephrine HCl Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling two bags of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride because they were made with recalled saline bags that may leak.
Product
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1023-2017·2017-08-02
SCA Pharmaceuticals Recalls Phenylephrine HCl Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl injection because the product lacks assurance of sterility and has the potential to leak.
Product
PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1020-2017·2017-08-02
SCA Pharmaceuticals Recalls NORepinephrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL due to lack of assurance of sterility and potential for leaking.
Product
NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1030-2017·2017-08-02
SCA Pharmaceuticals Recalls Phenylephrine IV Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling Phenylephrine 20 mg IV bags due to a lack of assurance of sterility and potential for leaking.
Product
PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0977-2017·2017-07-19
SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 660 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The product was distributed in LA, PA, NY, and WI.
Product
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-0979-2017·2017-07-19
SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 20 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The affected product was distributed in LA, PA, NY, and WI.
Product
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-0976-2017·2017-07-19
SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 221 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The product was distributed in LA, PA, NY, and WI.
Product
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-0955-2017·2017-07-19
Advanced Pharma Recalls Potassium Phosphate Bags Due to Sterility Concerns
Advanced Pharma Inc. is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride bags because the company cannot assure the product's sterility.
Product
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2531-2017·2017-06-21
Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance
Creganna Medical Devices is recalling 100 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.
Product
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2530-2017·2017-06-21
Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance
Creganna Medical Devices is recalling 150 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance. The devices were distributed in Massachusetts.
Product
Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-0779-2017·2017-05-24
Key Pharmacy Recalls Sodium Carboxymethylcellulose Ophthalmic Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Sodium Carboxymethylcellulose 0.5% Ophthalmic Solution because the firm cannot ensure the product is sterile.
Product
SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0760-2017·2017-05-24
FDA Recalls Compounded Injection Due to Lack of Sterility Assurance
Key Pharmacy and Compounding Center is recalling CHOL/IN/ME(L)/B6 10ML MDV injection due to lack of assurance of sterility.
Product
CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0724-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.
Product
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
Category
Drug
Distribution
Distributed nationwide