The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 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 1691

  • 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-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-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-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-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-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-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-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-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-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-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-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
  • 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-0964-2022·2022-06-08

    Oxytocin Injectable Drug Recalled for Lack of Sterility

    Nephron Sterile Compounding Center has recalled 3,587 bags of Oxytocin injectable nationwide due to lack of assurance of sterility.

    Product
    Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0955-2022·2022-06-08

    Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.

    Product
    Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 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: 69374-903-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0962-2022·2022-06-08

    Lidocaine Injectable Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.

    Product
    Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 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: 69374-949-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0907-2022·2022-06-01

    FDA Recalls Sodium Tetradecyl Sulfate Injectable Over Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 1.5% Injection (480 vials, Lot B24308-22) due to lack of assurance of sterility. The injectable was distributed nationwide.

    Product
    Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0931-2022·2022-06-01

    Lidocaine-Epinephrine Injectable Vials Recalled for Sterility Assurance Failure

    Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000 injection vials due to lack of sterility assurance. The recall affects 310 vials distributed nationwide.

    Product
    Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0099-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0917-2022·2022-06-01

    Alpha Lipoic Acid injection vials recalled for sterility assurance defect

    Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL due to inability to assure sterility. Patients should contact their healthcare provider to verify their medication and discuss alternatives.

    Product
    Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0076-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0927-2022·2022-06-01

    Compounded Injectable Formula F1 Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy is recalling Formula F1, a compounded injectable medication, due to lack of sterility assurance. The 1,703 vials were distributed nationwide.

    Product
    Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0943-2022·2022-06-01

    Ondansetron Hydrochloride vials recalled due to sterility assurance concerns

    Olympia Compounding Pharmacy recalls 911 vials of Ondansetron Hydrochloride (1 mg/mL) due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.

    Product
    Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0127-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0936-2022·2022-06-01

    Methylcobalamin Injectable Recalled for Lack of Sterility Assurance

    Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.

    Product
    Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide