Hazard

Sterility Failure recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility failure 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.

351–375 of 462

HighFDA (Drugs)·D-1281-2022·2022-07-27
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 18,840 syringes of Succinylcholine Chloride Injection nationwide because the manufacturing process cannot be assured to have maintained sterility.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-919-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1280-2022·2022-07-27
Anticoagulant Sodium Citrate Solution Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 85,300 pre-filled syringes of Anticoagulant Sodium Citrate Solution due to failure to assure sterility. Affected patients should contact their healthcare provider.
Product
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1274-2022·2022-07-27
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling Phenylephrine HCl Injection syringes due to lack of assurance of sterility. Approximately 75,630 syringes distributed nationwide are affected.
Product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1267-2022·2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection syringes distributed nationwide due to lack of assurance of sterility. Approximately 43,385 syringes are affected.
Product
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1260-2022·2022-07-27
Ketamine HCl Injection Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection pre-filled syringes due to lack of assurance of sterility. The recall affects 30,745 syringes distributed nationwide.
Product
Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1268-2022·2022-07-27
Morphine Sulfate Injection Recalled Due to Sterility Assurance Concerns
Nephron Sterile Compounding Center LLC is recalling morphine sulfate injection syringes due to lack of assurance of sterility. The recall affects 4,620 pre-filled syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1275-2022·2022-07-27
Phenylephrine HCl injection recalled for lack of sterility assurance
Nephron Sterile Compounding Center recalls Phenylephrine HCl Injection syringes nationwide due to lack of sterility assurance. Patients with affected lots should contact their healthcare provider.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1195-2022·2022-07-20
Ascorbic Acid Injectable Vials Recalled Due to Sterility Assurance Failure
Tailor Made Compounding is recalling ascorbic acid injectable vials due to lack of sterility assurance. The affected vials were distributed nationwide and in Puerto Rico.
Product
Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1196-2022·2022-07-20
BCAA Injection Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 180 vials of BCAA (branched-chain amino acid) injections nationwide due to inability to assure the product maintained sterility. Affected batches expire between April and June 2022.
Product
BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1189-2022·2022-07-20
Drug Recall: Draximage MAA Injectable Kit Due to Sterility Failure
Jubilant Draximage Inc. is recalling Draximage MAA, an injectable diagnostic drug kit, due to failed endotoxin testing. The recall affects 519 cartons distributed nationwide (Lot 1H005, expiration November 30, 2023).
Product
DRAXIMAGE MAA — DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1237-2022·2022-07-20
FDA Recalls Compounded Testosterone Injection for Sterility Assurance
Tailor Made Compounding is recalling 93 vials of Testosterone Enanthate due to lack of assurance of sterility. The affected batches were distributed nationwide and in Puerto Rico.
Product
Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1242-2022·2022-07-20
Vitamin D3 50,000IU Compounded Product Recalled for Sterility Assurance Failure
Tailor Made Compounding has recalled Vitamin D3 50,000IU/mL vials nationwide due to lack of sterility assurance during manufacturing. No illnesses have been reported.
Product
Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1203-2022·2022-07-20
FDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
Tailor Made Compounding is recalling 90 vials of GAC (Glutamine/Arginine/L-Carnitine) injectable solution distributed nationwide and in Puerto Rico due to lack of assurance of sterility.
Product
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1207-2022·2022-07-20
Gonadorelin Drug Vials Recalled Due to Sterility Assurance Failure
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Product
Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1218-2022·2022-07-20
Methylene Blue Hypotonic Solution Vials Recalled for Sterility Assurance Failure
Methylene Blue Hypotonic Solution vials are being recalled nationwide and in Puerto Rico due to lack of assurance of sterility. Affected vials should not be used.
Product
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1233-2022·2022-07-20
Compounded Testosterone/Anastrozole Injectable Vials Recalled for Sterility Assurance
Tailor Made Compounding is recalling 106 vials of compounded testosterone/anastrozole injectable due to lack of sterility assurance. The product was distributed nationwide in the USA and Puerto Rico.
Product
Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1194-2022·2022-07-20
Compounded Testosterone-Anastrozole Injectable Vials Recalled for Sterility Concerns
Tailor Made Compounding recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.
Product
Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1238-2022·2022-07-20
Compounded Testosterone Enanthate Injectables Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 414 vials of Testosterone Enanthate 200mg/ml (5 mL and 10 mL) due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Product
Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1220-2022·2022-07-20
Nandrolone Decanoate Injectable Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.
Product
Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1192-2022·2022-07-20
Alpha Lipoic Acid injectable vials recalled for sterility assurance failure
TMC Acquisition LLC is recalling Alpha Lipoic Acid 25mg/mL vials due to lack of assurance of sterility in manufacturing. The product was distributed nationwide.
Product
Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1154-2022·2022-06-29
Testosterone Cypionate Injectable Recalled Due to Manufacturing Sterility Deviation
Sun Pharmaceutical is recalling approximately 47,500 vials of Testosterone Cypionate Injection due to a manufacturing deviation that may have affected product sterility.
Product
TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1143-2022·2022-06-22
Prefilled Syringes of Medroxyprogesterone Acetate Recalled for Lack of Sterility Assurance
Afaxys Pharma is recalling 79,339 prefilled syringes of medroxyprogesterone acetate because the manufacturer could not assure sterility. The syringes were distributed nationwide.
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1144-2022·2022-06-22
Medroxyprogesterone Acetate Injectable Suspension Recalled for Sterility Assurance Failure
Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension due to lack of assurance of sterility. The recall affects approximately 57,997 prefilled syringes distributed nationwide.
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 16714-999-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1147-2022·2022-06-22
Medroxyprogesterone acetate injectable vials recalled for lack of sterility assurance
Sun Pharmaceutical is recalling 26,892 vials of medroxyprogesterone acetate injectable suspension (150 mg/mL) distributed nationwide due to lack of assurance of sterility. The affected lots expire between January and June 2023.
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1145-2022·2022-06-22
Medroxyprogesterone Acetate Injectable Suspension Recalled for Sterility Concerns
Sun Pharmaceutical is recalling 4,625 syringes of Medroxyprogesterone Acetate Injectable Suspension (Lot HAC1951A) due to lack of assurance of sterility. The affected medication was distributed nationwide.
Product
MEDROXYPROGESTERONE ACETATE — MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE)
Category
Drug
Distribution
Distributed nationwide