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.

401–425 of 2383

HighFDA (Drugs)·D-0053-2020·2019-10-09
KRS Global Biotechnology Recalls Glutathione Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0110-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,747 vials of Vitamin 10 B Lyophilized for IM use nationwide due to a lack of assurance of sterility.
Product
Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0066-2020·2019-10-09
Labetalol HCl syringes are recalled due to lack of sterility assurance
The FDA is recalling 6,405 units of Labetalol HCl single-dose syringes because there was insufficient assurance of sterility during production. No illnesses or injuries have been reported.
Product
Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1843-2019·2019-08-28
SCA Pharmaceuticals Recalls Ketamine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 922 syringes of Ketamine 50 mg/5 mL injection due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1756-2019·2019-08-21
Infusion Options Recalls Carboplatin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Carboplatin infusion bags because the company cannot guarantee the products are sterile.
Product
CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARBOPLATIN 750 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 895 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 235 MG / 250ml NS IVPB CARBOPLATIN 716 MG / 250 ML D5W IVPB; CARBOPLATIN 400 MG / 500 ML NS IVPB; CARBOPLA
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1818-2019·2019-08-21
Infusion Options Recalls Vincristine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific vincristine infusion products in New York due to a lack of assurance of sterility.
Product
VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRISTINE 2 MG /100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1759-2019·2019-08-21
Infusion Options Recalls Cisplatin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.
Product
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1771-2019·2019-08-21
Infusion Options Recalls Doxorubicin Liposomal Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Doxorubicin Liposomal and combination chemotherapy infusions in New York due to a lack of assurance of sterility.
Product
Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Doxorubicin 16 MG/1000 ML
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1808-2019·2019-08-21
Infusion Options Recalls Remicade Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Remicade infusion bags in New York due to a lack of assurance of sterility.
Product
REMICADE 680 MG QS 250 ML 0.9% NACL IVPB; REMICADE 270 MG QS 250 ML 0.9% NACL IV; REMICADE 730 MG QS 250 ML 0.9% NACL IVPB REMICADE 330 MG QS 250 ML 0.9% NACL IVPB; REMICADE 740 MG IN 250 ML NS IVPB; REMICADE 650 MG / 250 ml 0.9% NACL; REMICADE 1200 MG/250 ml 0.9% NACL IVPB; REM
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1758-2019·2019-08-21
Infusion Options Recalls Cetuximab IV Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Cetuximab 335 mg/167.5 mL IV infusions in New York due to a lack of assurance of sterility.
Product
CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1765-2019·2019-08-21
Infusion Options Recalls DARZALEX Infusion Bags Due to Sterility Concerns
Infusion Options, Inc. is recalling DARZALEX 1008 mg / 500 mL IV infusion bags in New York due to a lack of assurance of sterility.
Product
DARZALEX 1008 MG / 500 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-1766-2019·2019-08-21
Infusion Options Recalls Decitabine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Decitabine 40 mg/100 ml infusions in New York due to a lack of assurance of sterility.
Product
DECITABINE 40 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-1817-2019·2019-08-21
Infusion Options Recalls Vinblastine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Vinblastine infusions in New York due to a lack of assurance of sterility.
Product
VINBLASTINE 10.9 MG / 100 ML D5W IVPB; VINBLASTINE 10.8 MG / 100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1800-2019·2019-08-21
Infusion Options Recalls Paclitaxel Protein Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific paclitaxel protein infusion products in New York due to a lack of assurance of sterility.
Product
PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 355 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-1778-2019·2019-08-21
Infusion Options Recalls FOSAPREPITANT Due to Sterility Assurance Concerns
Infusion Options, Inc. is recalling FOSAPREPITANT 150 mg/150 ml NS IVPB in New York due to a lack of assurance of sterility.
Product
FOSAPREPITANT 150 mg/150 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-1809-2019·2019-08-21
Infusion Options Recalls Rituxan Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Rituxan infusion bags in New York due to a lack of assurance of sterility.
Product
RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN 700 MG QS 700 mL 0.9% NACL IVPB; RITUXAN 1000 MG / 350 mL 0.9% NACL IVPB RITUXAN 730 MG / 730 mL 0.9% NACL IVPB; RITUXAN 1000 MG QS 1000 ml NS; RITUXAN 10
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1786-2019·2019-08-21
Infusion Options Recalls Injectafer IV Products Due to Sterility Concerns
Infusion Options, Inc. is recalling Injectafer 720 mg and 210 mg IV products in New York due to a lack of assurance of sterility.
Product
INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 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-1773-2019·2019-08-21
Entyvio Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Entyvio 300 mg/250 mL due to a lack of assurance of sterility. The product was distributed in New York.
Product
ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1774-2019·2019-08-21
ERBITUX Infusions Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling ERBITUX infusion bags in New York due to a lack of assurance of sterility.
Product
ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1762-2019·2019-08-21
Infusion Options Recalls Cytarabine Products Due to Sterility Concerns
Infusion Options, Inc. is recalling Cytarabine products in New York due to a lack of assurance of sterility.
Product
Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS 6 ML PF NS SYRINGE; Cytarabine 100 MG QS 3 ML PF NS SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1781-2019·2019-08-21
Infusion Options Recalls Gemcitabine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Gemcitabine infusion bags in New York due to a lack of assurance of sterility.
Product
Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine 17
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1750-2019·2019-08-21
Infusion Options Recalls Avastin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Avastin infusion products because of a lack of assurance of sterility. The recall is limited to New York.
Product
AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360 MG
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1784-2019·2019-08-21
Infusion Options Recalls Ifosfamide Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Ifosfamide and Mesna infusion bags in New York due to a lack of assurance of sterility.
Product
IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1763-2019·2019-08-21
Infusion Options Recalls Dacarbazine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Dacarbazine infusions in New York due to a lack of assurance of sterility.
Product
DACARBAZINE 680 MG in 250 ml NS; DACARBAZINE 675 MG in 250 ml NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1805-2019·2019-08-21
Infusion Options Recalls Pertuzumab IV Bags Due to Sterility Concerns
Infusion Options, Inc. is recalling Pertuzumab IV bags in New York due to a lack of assurance of sterility.
Product
PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state