The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) 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 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.

801–825 of 2383

  • SevereFDA (Drugs)·D-1031-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Phenylephrine 50 mg injection due to a lack of assurance of sterility and potential for product leakage.

    Product
    PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1006-2017·2017-08-02

    SCA Pharmaceuticals Recalls Bupivacaine HCl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Bupivacaine HCl 0.125% bags due to a lack of assurance of sterility and potential for leaking.

    Product
    BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1029-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Phenylephrine 200 mg in 0.9% Sodium Chloride 250 mL injections due to a lack of assurance of sterility and potential for leaking.

    Product
    PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1014-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags Due to 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 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1008-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl injection bags due to a lack of assurance of sterility and potential for leaking.

    Product
    fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1015-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags because they may leak and lack assurance of sterility.

    Product
    fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1013-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl infusion bags because they may leak and lack assurance of sterility.

    Product
    fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1007-2017·2017-08-02

    SCA Pharmaceuticals Recalls Bupivacaine HCl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Bupivacaine HCl 0.2% bags because they may leak and lack sterility assurance.

    Product
    BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1012-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling fentanyl syringes because they may leak and lack assurance of sterility.

    Product
    fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1026-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine IV Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Phenylephrine 10 mg IV bags due to a lack of assurance of sterility and potential for leaking.

    Product
    PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1022-2017·2017-08-02

    SCA Pharmaceuticals Recalls Repinephrine Bitartrate Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Repinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for product leakage.

    Product
    NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1000-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 130 bags of fentanyl citrate injection due to a lack of assurance of sterility caused by potential leaks in the sodium chloride bags used.

    Product
    fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2017·2017-08-02

    SCA Pharmaceuticals Recalls Potassium Chloride Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL due to lack of assurance of sterility and potential for leaking.

    Product
    Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1034-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Infusion Bags

    SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.

    Product
    fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1018-2017·2017-08-02

    SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling ePHEDrine Sulfate syringes due to a lack of assurance of sterility and potential for leaking.

    Product
    ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1017-2017·2017-08-02

    SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Hydromorphone injection syringes because they may leak and lack assurance of sterility.

    Product
    Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1001-2017·2017-08-02

    SCA Pharmaceuticals Recalls CeFAZolin Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 108 bags of CeFAZolin 3 g in 0.9% Sodium Chloride because the product was made with recalled saline bags that may leak, compromising sterility.

    Product
    ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1025-2017·2017-08-02

    SCA Pharmaceuticals Recalls Phenylephrine HCl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of Phenylephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL bags because they may leak and lack assurance of sterility.

    Product
    PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1016-2017·2017-08-02

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling a specific lot of fentanyl and bupivacaine injection due to a lack of assurance of sterility and potential for leaking.

    Product
    fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1002-2017·2017-08-02

    SCA Pharmaceuticals Recalls Diltiazem Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Diltiazem 125 mg injection bags because they were made with recalled saline bags that may leak, compromising sterility.

    Product
    Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1019-2017·2017-08-02

    SCA Pharmaceuticals Recalls Epinephrine HCl Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Epinephrine HCl 4 mg in 0.9% Sodium Chloride 250 mL due to a lack of assurance of sterility and potential for leaking.

    Product
    EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0999-2017·2017-08-02

    SCA Pharmaceuticals Recalls Morphine Sulfate Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 220 bags of morphine sulfate in 0.9% sodium chloride because the product was made with recalled saline bags that may leak, compromising sterility.

    Product
    morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0988-2017·2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate Injection due to a media fill failure that raises concerns about sterility.

    Product
    Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0997-2017·2017-07-26

    PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns

    PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection because a media fill failure at the manufacturer raised concerns about sterility.

    Product
    Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2017·2017-07-19

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 54,528 bags of 5% Dextrose Injection because the bags may leak, compromising sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide