The Recall Desk

Hazard

Crystallization recalls

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

What the numbers show

Total
49
Critical
0
Severe
12
Most recent
2026-07-29

Of the 49 crystallization recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (24%) 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 crystallization 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.

1–25 of 49

  • ModerateFDA (Drugs)·D-0724-2026·2026-07-29

    Cyproheptadine Hydrochloride Syrup Recall Due to Precipitate

    Rising Pharma is recalling cyproheptadine hydrochloride syrup due to the presence of precipitate, including crystallization and floating particles in the bottle.

    Product
    CYPROHEPTADINE HYDROCHLORIDE — CYPROHEPTADINE HYDROCHLORIDE (CYPROHEPTADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0596-2026·2026-06-24

    Buprenorphine injection vials show crystallization identified as buprenorphine free base

    Buprenorphine HCl Injection, 0.3 mg/mL single dose vials, is being recalled because of crystallization identified as buprenorphine free base. 46,334 units are affected.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0172-2025·2025-01-08

    Dapsone Topical Gel Recalled Due to Crystallization Defect

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (2760 packs) distributed nationwide due to crystallization in the formulation. The voluntary recall affects lots T400514 and T400808.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0171-2025·2025-01-08

    Dapsone Gel Recalled Nationwide for Crystallization

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% nationwide due to crystallization detected in multiple lots. Patients should contact their pharmacy or healthcare provider for guidance.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2025·2024-11-13

    Dapsone Gel 7.5% recalled nationwide due to crystallization

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% due to crystallization. The voluntary recall covers 6,048 pumps distributed nationwide in the United States.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0034-2025·2024-11-13

    OTC cough and congestion medication recalled for crystallization

    Denison Pharmaceuticals is recalling its Maximum Strength Cough and Chest Congestion medication due to crystallization in bottles. The product, distributed by Genexa Inc., may contain chunks, graininess, or crystal substances that affect uniformity.

    Product
    MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK — MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0033-2025·2024-11-13

    OTC Cold and Cough Medication Recalled Due to Crystallization

    Denison Pharmaceuticals recalls Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo Pack due to crystallization and texture changes in affected bottles.

    Product
    MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK — MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0011-2025·2024-10-23

    Prescription Dapsone Gel 7.5% Recalled Due to Crystallization

    Viona Pharmaceuticals has voluntarily recalled 2,544 pumps of Dapsone Gel 7.5% (Lot #T400512) due to crystallization. The affected product was distributed in New York.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0144-2024·2023-12-13

    FDA Recalls SANDIMMUNE Oral Solution Due to Crystallization

    Novartis Pharmaceuticals is recalling SANDIMMUNE Oral Solution (cyclosporine 100 mg/mL) due to crystallization found in bottles. The affected lots were distributed nationwide.

    Product
    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2024·2023-11-15

    Buprenorphine HCl Injection Recalled for Crystallization Defect

    Buprenorphine HCl injection is being recalled nationwide due to white crystalline agglomeration found in stored product samples during routine inspection.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2023·2023-09-27

    Novartis Withdraws SANDIMMUNE Oral Solution Bottles Due to Crystallization

    Novartis is recalling SANDIMMUNE Oral Solution bottles nationwide because they were found to contain crystals. Patients should contact their pharmacy or prescriber about affected bottles.

    Product
    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0277-2022·2021-12-15

    Apollo Care VANComycin Injection Recalled for Crystallization

    Apollo Care is recalling VANComycin 1g in 0.9% Sodium Chloride injection due to crystallization that makes the product appear turbid. The affected lot was distributed in Missouri.

    Product
    VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0315-2021·2021-04-07

    Zydus Recalls Acyclovir Sodium Injection Due to Crystallization

    Zydus Pharmaceuticals is recalling Acyclovir Sodium Injection due to customer complaints of crystallization in the finished product.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2021·2021-04-07

    Zydus Recalls Acyclovir Sodium Injection Due to Crystallization

    Zydus Pharmaceuticals is recalling 1,638 packs of Acyclovir Sodium Injection due to customer complaints of crystallization in the finished product.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0522-2020·2019-12-04

    AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter

    AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2020·2019-10-23

    Ingenus Recalls Leucovorin Calcium Injection Due to Crystallization

    Ingenus Pharmaceuticals is recalling Leucovorin Calcium Injection vials due to the presence of particulate matter identified as API crystallization.

    Product
    Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1634-2019·2019-08-14

    RXQ Compounding Recalls Ascorbic Acid Injection Due to Crystallization

    RXQ Compounding LLC is voluntarily recalling Ascorbic Acid 500 MG/ML Injection due to crystallization. The recall covers all lots within expiry distributed nationwide.

    Product
    Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0173-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1636-2019·2019-08-14

    RXQ Compounding Recalls Ascorbic Acid Injection Due to Crystallization

    RXQ Compounding LLC is voluntarily recalling Ascorbic Acid 500 MG/ML Injection due to crystallization. The recall covers all lots within expiry distributed nationwide.

    Product
    Ascorbic Acid 500 MG/ML (Non-Corn) INJ (MDV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0975-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1635-2019·2019-08-14

    RXQ Compounding Recalls Ascorbic Acid Injection Due to Crystallization

    RXQ Compounding LLC is recalling Ascorbic Acid 400 MG/ML Injection Solution because of crystallization. The recall covers all lots within expiry distributed nationwide.

    Product
    Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0914-65
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0612-2018·2018-04-04

    Akorn Recalls 24-Hour Oral Care Kits Due to Low Chlorhexidine Levels

    Akorn, Inc. is recalling 24-Hour Oral Care q2 Kits because the chlorhexidine gluconate oral rinse contained in some units had low potency levels.

    Product
    24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0611-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Gluconate Oral Rinse Unit Dose Cups

    Akorn, Inc. is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups due to product crystallization and low assay results.

    Product
    Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0613-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Oral Rinse Kits

    Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.

    Product
    24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1124-2017·2017-09-06

    Amphastar Recalls Ketorolac Injection Due to Crystallization

    Amphastar Pharmaceuticals is recalling Ketorolac Tromethamine Injection because crystallization was observed in retained samples.

    Product
    Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1088-2017·2017-08-23

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Crystallization

    Akorn Inc is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups because crystallization caused subpotent assay results.

    Product
    Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1089-2017·2017-08-23

    Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

    Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

    Product
    Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
    Category
    Drug
    Distribution
    Distributed nationwide