The Recall Desk

Hazard

Sterility Failure recalls

1,693 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,693
Critical
12
Severe
938
Most recent
2026-09-30

Of the 1,693 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 938 (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.

426–450 of 1693

  • SevereFDA (Drugs)·D-0121-2022·2021-11-17

    Talon Compounding Pharmacy IVME SUPER B Injectable Recalled for Sterility Assurance

    Talon Compounding Pharmacy is recalling IVME SUPER B Injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States.

    Product
    IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0097-2022·2021-11-17

    Estradiol Valerate Injection Recalled Due to Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling Estradiol Valerate 20 mg/mL injection vials distributed across the United States, Puerto Rico, and Washington D.C. due to lack of assurance of sterility.

    Product
    Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0125-2022·2021-11-17

    Methylcobalamin Injectable Recalled for Sterility Assurance Failure

    Talon Compounding Pharmacy is recalling 324 vials of Methylcobalamin 1MG/ML injectable across the United States and Puerto Rico due to lack of assurance of sterility.

    Product
    METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0197-2022·2021-11-17

    TRI-MIX Injectable Medication Recalled for Sterility Assurance Failure

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of TRI-MIX PAPAVERINE/PHENTOLAMINE/PGE-1 injectable due to lack of assurance of sterility. The affected vial was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0143-2022·2021-11-17

    Sermorelin Acetate/Ipamorelin Vials Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Sermorelin Acetate 15MG/Ipamorelin 15MG lyophilized vials due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0218-2022·2021-11-17

    Compounded TRI-MIX Injectable Recalled for Lack of Sterility Assurance

    Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ injectable medication due to lack of assurance of sterility. The recall affects vials distributed across the United States, including Washington, D.C. and Puerto Rico.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0169-2022·2021-11-17

    Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

    Talon Compounding Pharmacy is recalling testosterone cypionate 100 mg/mL injectable in 12 lots due to lack of assurance of sterility. The affected product was distributed across the United States.

    Product
    TESTOSTERONE CYPIONATE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0172-2022·2021-11-17

    Testosterone Cypionate Anastrozole Injectable Recalled for Sterility Concerns

    Talon Compounding Pharmacy is recalling a testosterone cypionate and anastrozole injectable product due to lack of assurance of sterility. The recall affects nine vials distributed across the United States.

    Product
    TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0111-2022·2021-11-17

    Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 30 mg/mL Injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.

    Product
    ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0165-2022·2021-11-17

    Injectable testosterone and dutasteride recalled for lack of sterility assurance

    Talon Compounding Pharmacy is recalling 21 vials of injectable testosterone cypionate/dutasteride because the manufacturer cannot assure sterility of the product. The recall affects distribution across the United States, Washington D.C., and Puerto Rico.

    Product
    TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0130-2022·2021-11-17

    Talon Compounding Pharmacy Injectable MIC B Complex Sterility Recall

    Talon Compounding Pharmacy is recalling MIC B Complex with Chromium/Methylcobalamin injectable (Lot 09022021:50) due to lack of assurance of sterility. The product was distributed across the United States, Washington D.C., and Puerto Rico.

    Product
    MIC B COMPLEX W CHROMIUM/ METHYLCOB (BOYDEN) INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0167-2022·2021-11-17

    Injectable Compounded Drug Recall: Sterility Assurance Failure

    Vita Pharmacy, LLC (Talon Compounding Pharmacy) is recalling Test Cypionate 200mg/Dutasteride 2mg/mL injectable due to lack of sterility assurance. The affected lot was distributed across the United States.

    Product
    TEST CYPIONATE 200MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0103-2022·2021-11-17

    Alprostadil injectable recalled due to lack of sterility assurance

    Vita Pharmacy LLC (dba Talon Compounding Pharmacy) is recalling Alprostadil 32 mcg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington D.C. and Puerto Rico.

    Product
    ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0134-2022·2021-11-17

    Progesterone Injectable Recalled Due to Lack of Sterility Assurance

    Talon Compounding Pharmacy is recalling Progesterone 100mg/mL Injectable because the manufacturer cannot assure the product meets sterility requirements. The recall affects one vial distributed across the United States.

    Product
    PROGESTERONE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0208-2022·2021-11-17

    TRI-MIX Injectable Medication Recalled Due to Sterility Assurance Failure

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ injectable medication because the manufacturer lacks assurance of sterility.

    Product
    TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0184-2022·2021-11-10

    Flexible Intubation Videoscope Recall Due to Sterility Assurance Failure

    Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.

    Product
    FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Drugs)·D-0037-2022·2021-11-03

    Estradiol Valerate Injection Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable medication due to FDA inspection findings of inadequate sterility assurance. The product was distributed to approximately 494 patients across seven states.

    Product
    ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0004-2022·2021-10-13

    Betaxolol Ophthalmic Solution Recalled for Sterility Failure

    Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.

    Product
    Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0897-2021·2021-10-06

    ceFAZolin Injectable Drug Bags Recalled for Lack of Sterility Assurance

    IntegraDose Compounding Services is recalling ceFAZolin 3 G in 0.9% Sodium Chloride injectable bags due to lack of sterility assurance. The recall affects 589 bags distributed to New Hampshire, Massachusetts, and Minnesota.

    Product
    ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-2378-2021·2021-09-08

    Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure

    Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.

    Product
    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2021·2021-09-08

    Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure

    Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.

    Product
    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0736-2021·2021-08-25

    Teva Octreotide Acetate Injection Recalled for Sterility Assurance Failure

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.

    Product
    Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0733-2021·2021-08-25

    Amikacin Sulfate Injection Recalled Due to Sterility Assurance Failure

    Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.

    Product
    Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0730-2021·2021-08-25

    DAUNOrubicin Hydrochloride Injection Recalled Due to Sterility Assurance

    Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.

    Product
    DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0740-2021·2021-08-25

    Adenosine Injection Vials Recalled for Sterility Assurance Failure

    Teva Pharmaceuticals is recalling Adenosine Injection, USP 60mg/20mL vials nationwide due to lack of assurance of sterility. The recall affects 4,249 vials distributed nationwide, including Puerto Rico.

    Product
    Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
    Category
    Drug
    Distribution
    Distributed nationwide