The Recall Desk

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.

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.

676–700 of 1417

  • HighFDA (Drugs)·D-1468-2019·2019-07-17

    Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Testosterone Cypionate 100 mg/mL injections due to a lack of assurance of sterility. The product was distributed in Idaho and Washington.

    Product
    Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1422-2019·2019-07-03

    Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes nationwide due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1426-2019·2019-07-03

    Premier Pharmacy Labs Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 13,150 vials of Sodium Bicarbonate Injection 8.4% nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.

    Product
    Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1424-2019·2019-07-03

    Premier Pharmacy Labs Recalls Phenylephrine Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 1,040 syringes of Phenylephrine HCL injection nationwide because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1418-2019·2019-07-03

    Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 40 bags of Isoproterenol HCL in D5W due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1425-2019·2019-07-03

    Premier Pharmacy Labs Recalls Riboflavin 5-Phosphate Sodium Ophthalmic Solution

    Premier Pharmacy Labs is recalling 125 bottles of Riboflavin 5-Phosphate Sodium Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1420-2019·2019-07-03

    Premier Pharmacy Labs Recalls Mitomycin Irrigation Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 1,834 vials of Mitomycin Preservative Free Irrigation because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1419-2019·2019-07-03

    Premier Pharmacy Labs Recalls Lidocaine and Phenylephrine Injection Vials

    Premier Pharmacy Labs is recalling 323 vials of Lidocaine 0.5%/Phenylephrine 0.75% Injection due to a lack of sterility assurance identified during an FDA inspection.

    Product
    Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1412-2019·2019-07-03

    Premier Pharmacy Labs Recalls Brilliant Blue Ophthalmic Injection for Sterility Concerns

    Premier Pharmacy Labs is recalling 578 vials of Brilliant Blue Ophthalmic Injection due to a lack of assurance of sterility identified during an FDA inspection.

    Product
    Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1428-2019·2019-07-03

    Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling 1,721 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1335-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin Vials Due to Sterility Concerns

    Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 &6 vials nationwide because the product lacks sterility assurance.

    Product
    Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1330-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/Ipamorelin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling Sermorelin/Ipamorelin 18 mg/15 mg vials because they lack sterility assurance. The recall covers 24 vials distributed nationwide.

    Product
    Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1324-2019·2019-06-19

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

    Pharm D Solutions is recalling Human Chorionic Gonadotropin 10,000 IU vials due to a lack of sterility assurance. The recall affects 26 vials distributed nationwide.

    Product
    Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1331-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/GHRP-2 Vials Due to Sterility Concerns

    Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 9 mg/9 mg vials because they may lack sterility assurance. The recall covers 6 vials distributed nationwide.

    Product
    Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1337-2019·2019-06-19

    Pharm D Solutions Recalls Testosterone Cyp/Pro Vials for Sterility Concerns

    Pharm D Solutions is recalling 371 vials of Testosterone Cyp/Pro 95/5% due to a lack of sterility assurance. The affected prescription medication was distributed nationwide.

    Product
    Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1338-2019·2019-06-19

    Pharm D Solutions Recalls Testosterone Cypionate Vials for Sterility Concerns

    Pharm D Solutions is recalling specific lots of Testosterone Cypionate 200 mg/mL vials due to a lack of sterility assurance.

    Product
    Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1327-2019·2019-06-19

    FDA Recalls Ipamorelin Acetate Injectable Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 11 vials of Ipamorelin Acetate 9 mg/9mL Injectable due to a lack of sterility assurance.

    Product
    Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1323-2019·2019-06-19

    Pharm D Solutions Recalls B-Complex Injectable Vials Due to Sterility Concerns

    Pharm D Solutions, LLC is recalling specific lots of B-complex injectable vials due to a lack of sterility assurance. The affected product is distributed nationwide.

    Product
    B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1334-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/GHRP-2 &6 Vials for Sterility Concerns

    Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 &6 vials due to a lack of sterility assurance. The recall affects products distributed nationwide in the United States.

    Product
    Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1332-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/GHRP-2 Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 66 vials of Sermorelin/GHRP-2 because they lack sterility assurance. The products were distributed nationwide.

    Product
    Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1322-2019·2019-06-19

    Pharm D Solutions Recalls Bacteriostatic Water for Injection Vials

    Pharm D Solutions, LLC is recalling 716 vials of Bacteriostatic Water for Injection due to a lack of sterility assurance.

    Product
    Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1328-2019·2019-06-19

    Pharm D Solutions Recalls Lipo MIC-12 Injectable Vials for Sterility Concerns

    Pharm D Solutions, LLC is recalling 669 vials of Lipo MIC-12 injectable solution due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1255-2019·2019-05-08

    Customceutical Compounding Recalls Glutathione Injection Vials Due to Sterility Concerns

    Customceutical Compounding is recalling specific lots of compounded Glutathione 200mg/mL injection vials because the FDA could not ensure the products were sterile.

    Product
    Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1211-2019·2019-05-01

    Diltiazem 250 mg IV Bags Recalled for Lack of Sterility Assurance

    CMC Enterprise Pharmacy is recalling 1,475 bags of Diltiazem 250 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.

    Product
    Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1235-2019·2019-05-01

    CMC Enterprise Pharmacy Recalls Vancomycin Bags Due to Sterility Concerns

    CMC Enterprise Pharmacy is recalling 532 bags of Vancomycin 1000 mg in NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.

    Product
    Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
    Category
    Drug
    Distribution
    1 state