Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,423
Critical: 3
Severe: 1,055
Most recent: 2026-10-14

Of the 1,423 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 1,055 (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 1423

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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