Hazard

Injection Safety recalls

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

What the numbers show

Total: 19
Critical: 0
Severe: 14
Most recent: 2025-07-02

Of the 19 injection safety recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (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 injection safety 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.

1–19 of 19

SevereFDA (Drugs)·D-0474-2025·2025-07-02
Methylcobalamin Injectable Pre-filled Syringe Recalled for Sterility Concerns
Thrive Health Solutions is recalling Methylcobalamin Injectable 10mg/mL pre-filled syringes (Lot #H228307, expiration 12/27/2025) due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0485-2025·2025-07-02
Tirzepatide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide/Cyanocobalamin Injectable 15mg/1mg/mL pre-filled syringes (Lot C03065F) due to lack of assurance of sterility. The product was distributed nationwide in the USA.
Product
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0417-2024·2024-04-03
Injectable Phenylephrine Recall Due to Sterility Assurance Failure
SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 2024.
Product
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0229-2023·2023-02-01
Phenol 10% Injectable Vials Recalled for Sterility Assurance Failure
Pharmacy Innovations recalls Phenol 10% injectable vials distributed nationwide due to insanitary conditions at the manufacturing facility that compromised sterility assurance.
Product
PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1229-2022·2022-07-20
Teriparatide Injectable Syringes Recalled Due to Sterility Assurance Concerns
Tailor Made Compounding is recalling Teriparatide injectable syringes nationwide due to lack of assurance of sterility. Patients using affected batches should contact their healthcare provider immediately.
Product
Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0750-2022·2022-03-30
Fresenius Kabi Sodium Acetate Injection Recalled for Particulate Matter
Fresenius Kabi USA is recalling sodium acetate injection due to the presence of particulate matter composed of carbon, oxygen, iron, and trace elements in multiple lots distributed nationwide.
Product
SODIUM ACETATE — SODIUM ACETATE (SODIUM ACETATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0661-2022·2022-03-23
Trimix Injectable Vials Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Trimix (Alprostadil/Papaverine/Phentolamine) injectable vials distributed in North Carolina due to lack of assurance of sterility.
Product
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0394-2022·2022-02-02
ALUM Concentrate IV Bags Recalled for Lack of Sterility Assurance
Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) IV bags nationwide due to lack of assurance of sterility. The affected product is a prescription intravenous medication supplied in 300 ml bags.
Product
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0300-2022·2022-01-05
SterRx Midazolam Injection Recalled for Lack of Sterility Assurance
SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection (50 mg per 50 mL) distributed nationwide due to lack of assurance of sterility. The recall affects 15,660 bags from seven lots manufactured between November and December 2021.
Product
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0317-2022·2022-01-05
SterRx Fentanyl Citrate Injection recalled for lack of sterility assurance
SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.
Product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0181-2022·2021-11-17
Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 20 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
TESTOSTERONE CYPIONATE 20MG/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-0154-2022·2021-11-17
Talon Compounding Pharmacy Injectable Sterility Recall
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 1mg/ml injectable (4 vials) due to lack of assurance of sterility.
Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0149-2022·2021-11-17
Vitamin D3 Injectable from Talon Compounding Pharmacy Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling Vitamin D3 100,000 IU/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
VITAMIN D3 100,000 IU/ML INJECTABLE 100,000IU/ML, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0113-2022·2021-11-17
Estradiol Valerate Injectable Injection Lacks Sterility Assurance
Talon Compounding Pharmacy is recalling Estradiol Valerate 50 mg/mL injectable due to lack of assurance of sterility. The affected product is a prescription injection distributed across the United States, Puerto Rico, and Washington, D.C.
Product
ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE 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-0220-2022·2021-11-17
Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 4/PGE-1 20 injectable due to lack of assurance of sterility. The recall affects 13 vials distributed across the United States, Washington, D.C., and Puerto Rico.
Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 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-0065-2022·2021-11-03
MIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling MIT/B12 25/50/50MG/ML 1MG/ML multidose vials due to FDA inspection findings that raised concerns about the lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
Product
MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0744-2021·2021-08-25
Teva Octreotide Acetate Injection Recall: Sterility Assurance Loss
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Product
Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0735-2021·2021-08-25
Teva Vecuronium Bromide Injection Recalled for Sterility Assurance
Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.
Product
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
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