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.

51–75 of 2383

HighFDA (Drugs)·D-1526-2022·2022-09-21
Injectable Drug Recall: TRI-MIX 30/1/10 Vials Lack Sterility Assurance
Carolina Infusion is recalling TRI-MIX 30/1/10 injectable vials nationwide because the sterility of the product cannot be assured. This FDA Class II recall affects 16 vials distributed across multiple lots with expiration dates through October 2022.
Product
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1519-2022·2022-09-21
Semaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns
Carolina Infusion is recalling Semaglutide/Cyanocobalamin injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider if they received this product.
Product
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1328-2022·2022-08-17
Difluprednate eye drops recalled for defective container closure affecting sterility
Cipla is recalling Difluprednate ophthalmic emulsion nationwide due to defective container closures that compromise sterility assurance. Patients using the affected lot should discontinue use and contact their healthcare provider.
Product
DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1215-2022·2022-07-20
Injectable Methylcobalamin recalled due to lack of sterility assurance
Tailor Made Compounding is recalling 652 vials of Methylcobalamin 10mg/mL injectable due to lack of assurance of sterility. No illnesses or injuries have been reported.
Product
Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0960-2022·2022-06-08
Ketamine Hydrochloride Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine Hydrochloride Injection due to lack of assurance of sterility. The recall affects 107,530 pre-filled syringes distributed nationwide.
Product
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0947-2022·2022-06-01
Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling QM-2, a compounded multi-dose injectable medication, because the manufacturer cannot assure the product's sterility. The recall affects 619 vials distributed nationwide.
Product
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0937-2022·2022-06-01
MICC Injectable Drug Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 5,334 vials of MICC injectable due to lack of sterility assurance. Distribution was nationwide in the USA, Puerto Rico, and US Virgin Islands.
Product
MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0377-2021·2021-05-26
Teva Recalls Metoclopramide Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Metoclopramide Injection because there is a lack of assurance of sterility. The product was distributed nationwide.
Product
METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0376-2021·2021-05-26
Teva Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension due to a lack of assurance of sterility.
Product
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0378-2021·2021-05-26
Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Haloperidol Decanoate Injection because the company cannot guarantee the product is sterile.
Product
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0375-2021·2021-05-26
Teva Recalls Haloperidol Decanoate Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling 3,150 vials of Haloperidol Decanoate Injection due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0374-2021·2021-05-26
Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Leucovorin Calcium for Injection because the company cannot guarantee the product is sterile.
Product
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 194
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1298-2021·2021-03-31
Teleflex Recalls PLEUR-EVAC Thoracic Catheters Due to Sterility Concerns
Teleflex is recalling 520 PLEUR-EVAC Thoracic Catheters because the company cannot guarantee the devices are sterile.
Product
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in stra
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0305-2021·2021-03-24
Sagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns
Sagent Pharmaceuticals is recalling specific lots of Phenylephrine Hydrochloride Injection due to customer complaints of loose vial overseals that may compromise sterility.
Product
PHENYLEPHRINE HYDROCHLORIDE — PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0277-2021·2021-03-03
Teva Recalls Metoclopramide Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Metoclopramide Injection because manufacturing areas exceeded microbial acceptance levels, creating a lack of sterility assurance.
Product
METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0285-2021·2021-03-03
Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0280-2021·2021-03-03
Teva Recalls Epoprostenol Sodium Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0279-2021·2021-03-03
Teva Recalls Vecuronium Bromide Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling specific lots of Vecuronium Bromide for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.
Product
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0272-2021·2021-03-03
Teva Recalls Desmopressin Acetate Injection Due to Sterility Concerns
Teva Pharmaceuticals is recalling Desmopressin Acetate Injection because manufacturing areas exceeded microbial limits, compromising sterility assurance.
Product
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0288-2021·2021-03-03
Fludeoxyglucose F 18 Injection Recalled for Lack of Sterility Assurance
The General Hospital Corporation is recalling Fludeoxyglucose F 18 Injection due to a lack of assurance of sterility. The product was distributed to one direct account.
Product
FLUDEOXYGLUCOSE F 18 — FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0194-2021·2021-01-13
SCA Pharmaceuticals Recalls Glycopyrrolate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL due to a lack of assurance of sterility and potential defective caps.
Product
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0214-2021·2021-01-13
SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.
Product
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0189-2021·2021-01-13
SCA Pharmaceuticals Recalls ePHEDrine Sulfate Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate Injection due to a lack of assurance of sterility and potential defective syringe caps.
Product
ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0217-2021·2021-01-13
SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 9,942 syringes of Ketamine 50 mg/5mL injection due to a lack of assurance of sterility and potential defective syringe caps.
Product
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0196-2021·2021-01-13
SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 1,056 hydromorphone syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
Product
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Category
Drug
Distribution
Distributed nationwide