The Recall Desk

Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,383
Critical
1
Severe
2,113
Most recent
2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) 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 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.

626–650 of 2383

  • SevereFDA (Drugs)·D-0174-2019·2018-11-07

    Pharm D Solutions Recalls Prostaglandin E1 Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Prostaglandin E1 40 mcg/mL Injectable because the agency cannot assure the product is sterile.

    Product
    Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1347-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0211-2019·2018-11-07

    Pharm D Solutions Recalls Water for Injection Bags Due to Sterility Concerns

    Pharm D Solutions is recalling 12 bags of Water Sterile for Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix T105 injectable solution because the company cannot ensure the product is sterile.

    Product
    Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0148-2019·2018-11-07

    Pharm D Solutions Recalls Calcium Gluconate Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Calcium Gluconate 10% Injectable because the company cannot guarantee the product is sterile.

    Product
    Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2019·2018-11-07

    Pharm D Solutions Recalls Bi-Mix Injection Due to Sterility Concerns

    Pharm D Solutions is recalling Bi-Mix Injection (Alprostadil/Lidocaine) because the company cannot ensure the product is sterile. The recall covers nationwide distribution.

    Product
    Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0155-2019·2018-11-07

    Pharm D Solutions Recalls Glycerin Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Glycerin 72% Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1401-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0158-2019·2018-11-07

    Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling HCG Reconstitued 6000 IU Injectable vials because the company cannot ensure the product is sterile.

    Product
    HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0143-2019·2018-11-07

    Bi-Mix Injection Recalled Due to Lack of Assurance of Sterility

    Pharm D Solutions is recalling Bi-Mix Injection due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0185-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 108 vials of Sermorelin/GHRP-2/Theanine/Mannitol powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1731-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0176-2019·2018-11-07

    Pharm D Solutions Recalls Pyridoxine Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Pyridoxine 100 mg/mL injectable vials due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1614-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0136-2019·2018-11-07

    Pharm D Solutions Recalls Acetylcysteine Injection Due to Sterility Concerns

    Pharm D Solutions is recalling Acetylcysteine Injection 10 mg/5 mL because the agency could not ensure the product was sterile.

    Product
    Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0167-2019·2018-11-07

    Pharm D Solutions Recalls Magnesium IV Solution Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Magnesium 40 gm/ns 1000 mL IV solution because there is a lack of assurance of sterility.

    Product
    Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0135-2019·2018-11-07

    Avella Recalls Phenylephrine Infusion Bags Due to Sterility Concerns

    Avella of Deer Valley is recalling 300 bags of Phenylephrine 30 mg in NS 250 mL due to a lack of assurance of sterility.

    Product
    Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0190-2019·2018-11-07

    Pharm D Solutions Recalls Tri-Mix XL Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 553 vials of Tri-Mix XL injectable and powder nationwide due to a lack of assurance of sterility.

    Product
    Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0165-2019·2018-11-07

    Pharm D Solutions Recalls Levocarnitine Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Levocarnitine 170 mg/mL Injectable because the product lacks assurance of sterility. The recall covers 3,000 milliliters distributed nationwide.

    Product
    Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0199-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 715 vials of Trimix powder nationwide due to a lack of assurance of sterility.

    Product
    Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2019·2018-11-07

    Pharm D Solutions Recalls HCG Lyophilized Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 2,219 vials of HCG Lyophilized 5000 IU Injectable because the product lacks assurance of sterility.

    Product
    HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0178-2019·2018-11-07

    Pharm D Solutions Recalls Reck Injection Due to Sterility Concerns

    Pharm D Solutions is recalling 517 syringes of Reck Injection because the product lacks assurance of sterility. The recall covers lots distributed nationwide.

    Product
    Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0149-2019·2018-11-07

    Pharm D Solutions Recalls Calcium Gluconate Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Calcium Gluconate 2.5% products due to a lack of assurance of sterility.

    Product
    Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2019·2018-10-10

    Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns

    Pfizer is recalling 12,416 vials of Elelyso (taliglucerase alfa) because loose metal ferrule crimps may compromise sterility.

    Product
    ELELYSO — ELELYSO (TALIGLUCERASE ALFA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2018·2018-09-05

    Auro Pharmacies Recalls Glutathione Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 183 vials of Glutathione injectable because inadequate processes and equipment were used to assure the sterility of the product.

    Product
    Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1162-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 81 vials of Methyl-Cobalamin injectable because processes and equipment were inadequate to assure sterility.

    Product
    Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1147-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 5,718 vials of Human Chorionic Gonadotropin 5000 IU due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide