The Recall Desk

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.

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.

1276–1300 of 1423

  • SevereFDA (Drugs)·D-0156-2016·2015-11-04

    Park Compounding Pharmacy Recalls Prostaglandin PGE-1 Due to Sterility Concerns

    Park Compounding Pharmacy is recalling specific vials of Prostaglandin PGE-1 because the agency could not ensure the products remained sterile.

    Product
    PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0096-2016·2015-11-04

    Moses Lake Pharmacy Recalls Hydroxocobalamin Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling Hydroxocobalamin syringes because the FDA cannot assure the products are sterile.

    Product
    HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 3 mg/0.25 mL, syringe sizes: 20 mL and 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2016·2015-11-04

    Moses Lake Pharmacy Recalls Compounded Testosterone Cypionate Injectable Solution

    Moses Lake Professional Pharmacy is recalling compounded Testosterone Cypionate injectable solution due to a lack of assurance of sterility.

    Product
    TESTOSTERONE CYPIONATE (COMPOUNDED), Injectable Solution, 200 MG/ML, syringe sizes: 5mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0117-2016·2015-11-04

    FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling compounded progesterone pellets because the agency cannot ensure they are sterile. Consumers should stop using the product and contact their healthcare provider.

    Product
    PROGESTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0140-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 90 mg testosterone pellets because the agency could not ensure the sterile compounded drugs were sterile.

    Product
    TESTOSTERONE, Pellet, 90 mg, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0057-2016·2015-11-04

    FDA Recalls Alprostadil/Procaine Injectable Solution Due to Sterility Concerns

    The FDA is recalling 27 vials of Alprostadil/Procaine Injectable Solution because the manufacturer cannot ensure the product is sterile.

    Product
    ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0078-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    JD & SN Inc. is recalling Estradiol pellets because the FDA determined there is a lack of assurance of sterility for all sterile human compounded drugs within their expiry.

    Product
    ESTRADIOL, Pellet, 12.5 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0158-2016·2015-11-04

    Park Compounding Pharmacy Recalls TRI-MIX Vials Due to Sterility Concerns

    Park Compounding Pharmacy is recalling specific lots of TRI-MIX vials because the agency could not ensure the products were sterile.

    Product
    TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0010-2016·2015-10-21

    Nephron Recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

    Nephron Pharmaceuticals is recalling Ipratropium Bromide and Albuterol Sulfate inhalation solution due to a lack of assurance of sterility.

    Product
    IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1833-2015·2015-10-07

    Medistat RX Recalls Sterile Products Due to Sterility Assurance Concerns

    Medistat RX L.L.C. is recalling all sterile products, including various injectable medications, due to a lack of assurance of sterility.

    Product
    All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An Incomplete List of Recalled Products Includes 1) All Cyanacobalamin Products, 2) All Magnesium Chloride Products, 3) All Lipostat (MIC B12) Products, 4) All Trimix…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2799-2015·2015-09-30

    Regard Custom Surgical Pack Recalled for Chemical Contamination and Sterility Issues

    Resource Optimization & Innovation Llc is recalling 67 Regard Custom Surgical Packs due to potential chemical contamination and lack of sterility assurance.

    Product
    Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2798-2015·2015-09-30

    Regard Custom Surgical Pack Recalled Due to Chemical Contamination and Sterility Concerns

    Resource Optimization & Innovation Llc is recalling 24 Regard Custom Surgical Packs because they may contain chemically contaminated scrub products and lack sterility assurance.

    Product
    Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1743-2015·2015-09-23

    Testosterone Sterile Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone 12.5 mg sterile pellets due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1576-2015·2015-09-23

    Compounded Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling a compounded injection due to FDA-identified GMP violations that impact sterility assurance.

    Product
    Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2015·2015-09-23

    DMPS Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling DMPS injectable vials due to FDA inspection findings of GMP violations that impact sterility.

    Product
    DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1472-2015·2015-09-23

    Estradiol Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Estradiol 3 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1471-2015·2015-09-23

    Estradiol Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Estradiol 25 mg sterile pellets nationwide due to GMP violations that may impact sterility.

    Product
    Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1626-2015·2015-09-23

    Progesterone Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Progesterone 100 mg/ml Injection due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2015·2015-08-05

    Symmetry Surgical Disposable Towel Clamp Recalled for Sterility Assurance

    Symmetry Surgical is recalling 2,708 units of disposable towel clamps due to a lack of sterility assurance. The affected sterile products were distributed in the US, Germany, and Mexico.

    Product
    SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Drugs)·D-1190-2015·2015-07-08

    Lincare Recalls Diphenhydramine Syringes Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Diphenhydramine HCl syringes because the sterility of the product is not assured.

    Product
    Diphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1183-2015·2015-07-08

    Lincare Recalls Deferoxamine Mesylate IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Deferoxamine Mesylate IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    DEFEROXAMINE MESYLATE 3gm / NS 240mL Accuflo, Packaged in 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1203-2015·2015-07-08

    Lincare Recalls Fluorouracil IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1159-2015·2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded by United Medical IV Center because the sterility of the product is not assured.

    Product
    TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine, MgSO4, KCL, NaC, Zinc Cl; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Vitamin K, Ascorbic Acid, Rx Only. Compounded by…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1163-2015·2015-07-08

    Lincare Recalls TPN 3:1 Bags Due to Sterility Concerns

    Lincare, Inc. is recalling TPN 3:1 bags compounded in Arkansas between May 14 and May 27, 2015, because the sterility of the product is not assured.

    Product
    TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes KCL, K Phos, MgSO4, NaCl, Zinc Cl, Ca Gluconate; Vitamins, trace elements and medications Trace Ele.-Ped, Infuvite Pediat, Carnitor, Rx Only. Compounded by…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1201-2015·2015-07-08

    Lincare Recalls Ceftazidime IV Bags Due to Sterility Concerns

    Lincare, Inc. is recalling compounded Ceftazidime IV bags because the sterility of the product is not assured.

    Product
    Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
    Category
    Drug
    Distribution
    1 state