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.

1351–1375 of 1417

  • SevereFDA (Drugs)·D-436-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Injectable Drug Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Papav/Phentol/PG E1 injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-455-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls VIGAMOX Syringes Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling 204 doses of VIGAMOX (moxifloxacin) syringes because sterility cannot be assured after another product was found non-sterile.

    Product
    VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-419-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Epinephrine Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Epinephrine products because sterility cannot be assured after a related product was found non-sterile.

    Product
    EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-440-2014·2014-01-22

    Polidocanol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Polidocanol 3% injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-432-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Multitrace-4 Pediatric Injection

    Specialty Medicine Compounding Pharmacy is recalling Multitrace-4 pediatric injections because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-411-2014·2014-01-22

    FDA Recalls Aluminum Potassium Sulfate Sterile Powder Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Aluminum Potassium Sulfate Sterile powder because sterility cannot be assured after a related product was found non-sterile.

    Product
    Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-417-2014·2014-01-22

    Dexamethasone Solution Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Dexamethasone Sodium Phosphate solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-441-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Potassium Phosphate Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Potassium Phosphate injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-418-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls EDETATE DISODIUM Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling EDETATE DISODIUM ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-445-2014·2014-01-22

    Sodium tetradecyl sulfate recalled due to lack of sterility assurance

    Specialty Medicine Compounding Pharmacy is recalling sodium tetradecyl sulfate injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-431-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling methylcobalamin injectable products because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Co
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-437-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Papaverine HCL Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Papaverine HCL injectable because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-434-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Naltrexone MDV Injectable

    Specialty Medicine Compounding Pharmacy is recalling Naltrexone MDV 1mg/mL injectable because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-458-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls 0.9% Sodium Chloride Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling 0.9% Sodium Chloride injectable and topical products because sterility cannot be assured after a related product was found non-sterile.

    Product
    0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-459-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling unexpired sterile compounded human and veterinary products because sterility cannot be assured after a related product was found non-sterile.

    Product
    DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-414-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Combo Eye Gel because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-425-2014·2014-01-22

    Hyaluronidase Recalled Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling Hyaluronidase products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-449-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Testos Cypionate Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Testos Cypionate injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-446-2014·2014-01-22

    Sodium Thiosulfate Injectable Recalled for Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Sodium Thiosulfate PF, 10% injectable, because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-410-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Acetylcysteine Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Acetylcysteine 20% Ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-429-2014·2014-01-22

    Magnesium Sulfate Injection Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Magnesium Sulfate injections because sterility cannot be assured after a related product was found non-sterile.

    Product
    Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-433-2014·2014-01-22

    Naloxone Injectable Recalled Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling Naloxone HCL 0.4mg/mL injectable because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-426-2014·2014-01-22

    Hydroxocobalamin Injectable Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin 10,000 mcg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-454-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Vancomycin Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Vancomycin HCL 10 mg/mL Ophthalmic Solution because sterility cannot be assured. The product was distributed to healthcare providers and patients in Michigan.

    Product
    VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state