The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.

651–675 of 1691

  • SevereFDA (Drugs)·D-1849-2019·2019-09-18

    AmEx Pharmacy Recalls Bevacizumab Syringes Due to Sterility Concerns

    Pacifico National, Inc. dba AmEx Pharmacy is recalling Bevacizumab intravitreal injections because of a lack of assurance of sterility. The recall covers all lots remaining within expiry in the Continental U.S. and Puerto Rico.

    Product
    Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1850-2019·2019-09-18

    FDA Recalls Bevacizumab Intravitreal Injection Due to Sterility Concerns

    AmEx Pharmacy is recalling Bevacizumab intravitreal injections because the product lacks assurance of sterility. The recall covers all lots remaining within expiry in the Continental U.S. and Puerto Rico.

    Product
    Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2497-2019·2019-09-18

    Aesculap Caiman Disposable Surgical Instrument Recalled for Sterility Concerns

    Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility that the sterility batch was insufficiently sterilized.

    Product
    CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2019·2019-09-18

    Aesculap Caiman Disposable Surgical Instruments Recalled for Sterility Concerns

    Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility of insufficient sterilization.

    Product
    CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1787-2019·2019-08-21

    Infusion Options Recalls Irinotecan Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Irinotecan infusion products in New York due to a lack of assurance of sterility.

    Product
    IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOTECAN 155 MG / 500 ml D5W IVPB; IRINOTECAN 75 MG / 250 ML NS IVPB; IRINOTECAN 140 MG / 250 ML NS IVPB; IRINOTECAN 317 MG /500 ML D5W
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1803-2019·2019-08-21

    Infusion Options Recalls Pemetrexed Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Pemetrexed infusion products in New York due to a lack of assurance of sterility.

    Product
    PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000 mg QS 100 ml 0.9% NACL IVPB; PEMETREXED 490 MG /100 ml NS IVPB; PEMETREXED 800 mg/ 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1687-2019·2019-08-14

    RXQ Compounding Recalls Moxifloxacin Ophthalmic Solution Due to Sterility Concerns

    RXQ Compounding LLC is recalling Moxifloxacin 0.5% Ophthalmic Solution syringes because the product lacks assurance of sterility.

    Product
    MOXIFLOXACIN 0.5% OPHTH SOLUTION SYRINGE, 1 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0973-81
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1688-2019·2019-08-14

    RXQ Compounding Recalls Neostigmine Methyl Sulfate Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Neostigmine Methyl Sulfate 1mg/mL Injection Syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0143-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1655-2019·2019-08-14

    RXQ Compounding Recalls Ephedrine Syringes Due to Sterility Concerns

    RXQ Compounding LLC is recalling Ephedrine 5mg/mL syringes nationwide because the product lacks assurance of sterility.

    Product
    EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0201-85
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1671-2019·2019-08-14

    RXQ Compounding Recalls Lidocaine Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Lidocaine HCL 1% Injection Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0174-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1647-2019·2019-08-14

    RXQ Compounding Recalls Dextrose 50% Injection Due to Sterility Concerns

    RXQ Compounding LLC is recalling Dextrose 50% Injection Solution vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    DEXTROSE 50% INJECTION SOLUTION (PF) VIAL, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0969-89
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1667-2019·2019-08-14

    RXQ Compounding Recalls Hydroxocobalamin Injections Due to Sterility Concerns

    RXQ Compounding LLC is recalling Hydroxocobalamin 1000 mcg/mL injections because the product lacks assurance of sterility.

    Product
    HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0926-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2019·2019-08-07

    Teleflex Recalls Rusch EasyCath Kits Due to Sterility Concerns

    Teleflex Medical is recalling 3,700 Rusch EasyCath Kits because they may not be sterile. The kits were distributed nationwide to eight states.

    Product
    Rusch EasyCath Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2019·2019-07-24

    DJO Aircast Sterile Cuff Recall Due to Sterility Concerns

    DJO, LLC is recalling 9 units of Aircast REF 3011 sterile cuffs because they may not meet sterility requirements.

    Product
    Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1477-2019·2019-07-17

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    First Pharma Associates is recalling Methylcobalamin 1 mg/mL Injection vials due to a lack of assurance of sterility.

    Product
    Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-1959-2019·2019-07-17

    Applied Medical Recalls Kii Fios First Entry Devices for Sterility Concerns

    Applied Medical Resources Corp is recalling Kii Fios First Entry devices because they may not have met sterility requirements, potentially exposing patients to infectious agents.

    Product
    Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1416-2019·2019-07-03

    Premier Pharmacy Labs Recalls Isoproterenol Bags Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 606 bags of Isoproterenol HCL in D5W because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1427-2019·2019-07-03

    Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns

    Premier Pharmacy Labs is recalling 6,423 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.

    Product
    SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-15, barcode 0 69623 23915 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1413-2019·2019-07-03

    Premier Pharmacy Labs Recalls Chlorpromazine Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 824 vials of Chlorpromazine HCL Injection because an FDA inspection found insufficient environmental controls that may compromise sterility.

    Product
    ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1417-2019·2019-07-03

    Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 1,235 bags of Isoproterenol HCL in D5W nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.

    Product
    Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, barcode 0 69623 24057 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1421-2019·2019-07-03

    Premier Pharmacy Labs Recalls Naloxone HCL Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling Naloxone HCL Preserved Injection because FDA inspections found insufficient environmental controls and lack of process validations, raising concerns about sterility assurance.

    Product
    Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1339-2019·2019-06-19

    Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix injectable vials due to a lack of sterility assurance.

    Product
    Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL 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-1325-2019·2019-06-19

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

    Pharm D Solutions is recalling 279 vials of Human Chorionic Gonadotropin 5,000 IU due to a lack of sterility assurance. The recall covers products distributed nationwide.

    Product
    Human Chorionic Gonadotropin 5,000 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-1326-2019·2019-06-19

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

    Pharm D Solutions is recalling 104 vials of Human Chorionic Gonadotropin 12,000 IU due to a lack of sterility assurance.

    Product
    Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1333-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 100 vials of Sermorelin/GHRP-2 & 6 due to a lack of sterility assurance. The products were distributed nationwide in the United States.

    Product
    Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide