The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 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 2,114 (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.

1976–2000 of 2384

  • ModerateFDA (Drugs)·D-1045-2015·2015-05-20

    Health Innovations Pharmacy Recalls Nifedipine and Lidocaine Jelly

    Health Innovations Pharmacy is recalling Nifedipine 0.2% - Lidocaine 2% Jelly due to sterility and stability concerns. The recall covers all lots distributed in North Carolina.

    Product
    Nifedipine 0.2% - Lidocaine 2% Jelly, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1019-2015·2015-05-20

    Health Innovations Pharmacy Recalls DHEA Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling DHEA 10 mg SR Capsules because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0431-2015·2015-04-15

    Navinta Recalls Fomepizole Injection Due to Sterility Assurance Concerns

    Navinta LLC is recalling Fomepizole Injection due to FDA inspection findings of GMP violations that may impact sterility. The recall covers 14,628 units distributed nationwide.

    Product
    Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0428-2015·2015-04-08

    Baxter Recalls Clinimix E Due to Sterility Assurance Concerns

    Baxter Healthcare is recalling 7,444 containers of Clinimix E 5/20 due to a lack of assurance of sterility and increased leak complaints.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0422-2015·2015-04-01

    Mylan Recalls Haloperidol Decanoate Injection Due to Sterility Concerns

    Mylan Institutional LLC is recalling Haloperidol Decanoate Injection because leaking vials raised concerns about the product's sterility.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0416-2015·2015-03-25

    Heritage Pharmaceuticals Recalls RIFAMPIN for Injection Due to Sterility Concerns

    Heritage Pharmaceuticals is recalling RIFAMPIN for Injection, USP, 600 mg per vial, due to quality control concerns regarding the assurance of sterility.

    Product
    RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0417-2015·2015-03-25

    Hospira Recalls 5% Dextrose Injection Due to Sterility Concerns

    Hospira is recalling 94,440 bags of 5% Dextrose Injection due to a potential leak at the administrative port that compromises sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2015·2015-03-11

    Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations suggest potential impacts on product sterility.

    Product
    Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2015·2015-03-11

    Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations regarding aseptic and GMP practices at the manufacturing site may have impacted product sterility.

    Product
    Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2015·2014-12-31

    Vann Healthcare Recalls Epinephrine Syringes Due to Sterility Concerns

    Vann Healthcare Services is recalling 410 epinephrine syringes because an FDA inspection found deficiencies that raise concerns about the pharmacy's ability to assure sterility.

    Product
    Epinephrine 1:1000, 0.15 mL packaged in 0.3 mL syringes, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0301-2015·2014-12-24

    Baxter Recalls Clinimix E IV Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 7,220 bags of Clinimix E IV solution because leaks were observed, raising concerns about sterility.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2015·2014-12-17

    Hospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Hospira Inc. is recalling Fentanyl Citrate Injection vials because improperly crimped flip-top seals may compromise sterility.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0296-2015·2014-12-17

    FDA Recalls Ondansetron Injection Vials Due to Sterility Concerns

    Fresenius Kabi USA is recalling 184,550 vials of Ondansetron Injection due to potential glass fractures and particles that compromise sterility.

    Product
    ONDANSETRON — ONDANSETRON (ONDANSETRON HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0278-2015·2014-12-03

    Hospira Recalls Potassium Chloride IV Bags Due to Sterility Concerns

    Hospira is recalling 836,460 bags of Potassium Chloride IV solution due to potential punctures that may compromise sterility and cause leaks.

    Product
    Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0284-2015·2014-12-03

    Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns

    Hospira is recalling 305,664 bags of Normosol-R Multiple Electrolytes Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0277-2015·2014-12-03

    Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns

    Hospira is recalling 152,172 bags of Normosol-R IV solution due to potential punctures that may compromise sterility and cause leaks.

    Product
    Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0287-2015·2014-12-03

    Hospira Recalls Sterile Water for Injection Due to Sterility Concerns

    Hospira is recalling 153,504 bags of Sterile Water for Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2015·2014-12-03

    Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Hospira is recalling 16.5 million bags of 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2014·2014-11-26

    Medtronic Recalls Patient Tracker Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling single-use Patient Tracker devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    PATIENT TRACKER 9733534XOM ENT 1PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1584-2014·2014-11-26

    Medtronic Recalls ENT Navigation Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 ENT PRGM 9734636 ADD FUSION NAV AxiEM devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    ENT PRGM 9734636 ADD FUSION NAV AxiEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1599-2014·2014-11-26

    Medtronic Recalls AxiEM Tumor Resonance Packs Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 AxiEM Tumor Resonance Packs because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    TUMOR RES. PACK 9733553 AxiEM S.M.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0223-2015·2014-11-12

    FDA Recalls Compounded Testosterone Cypionate Injectable Due to Sterility Concerns

    Oregon Compounding Centers is recalling compounded Testosterone Cypionate injectable vials due to quality control issues affecting sterility assurance.

    Product
    TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states