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.

26–49 of 49

  • LowFDA (Drugs)·D-1090-2017·2017-08-23

    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 q4, 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 # 97014
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1464-2016·2016-08-31

    Stratus Pharmaceuticals Recalls Remeven Cream Due to Crystallization

    Stratus Pharmaceuticals is recalling Remeven Cream because the product has crystallized. The recall covers specific lots of 5.0 oz and 9.0 oz tubes.

    Product
    Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1359-2016·2016-07-20

    Hospira Recalls Diazepam Injection Due to Crystallized Active Ingredient

    Hospira Inc. is recalling 373,850 tubes of Diazepam Injection USP 10mg/2mL because the product contains particulate identified as crystallized active ingredient.

    Product
    DIAZEPAM — DIAZEPAM (DIAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1242-2015·2015-07-22

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is recalling specific lots of Ketorolac Tromethamine Injection due to the presence of crystals identified as the calcium salt of Ketorolac.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1241-2015·2015-07-22

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is recalling Ketorolac Tromethamine Injections because crystallization was identified as the calcium salt of Ketorolac.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0974-2015·2015-05-13

    RemedyRepack Recalls Ketorolac Tromethamine Injection Due to Crystallization

    RemedyRepack Inc. is voluntarily recalling 25 vials of Ketorolac Tromethamine Injection 30 mg/mL due to crystallization. The product was distributed in Pennsylvania and Oklahoma.

    Product
    KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0973-2015·2015-05-06

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira is voluntarily recalling specific lots of Ketorolac Tromethamine Injections because of crystallization. The affected products were distributed nationwide, in Puerto Rico, and in Guam.

    Product
    Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0972-2015·2015-05-06

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The recall covers products distributed nationwide, in Puerto Rico, and in Guam.

    Product
    Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0482-2015·2015-04-15

    Hospira Recalls Ketorolac Tromethamine Injection Due to Crystallization

    Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection because of crystallization. The affected vials were distributed nationwide and in Guam and Singapore.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0483-2015·2015-04-15

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The recall covers vials distributed nationwide and internationally.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0484-2015·2015-04-15

    RemedyRepack Recalls Ketorolac Tromethamine Injection Vials Due to Crystallization

    RemedyRepack Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The affected vials were distributed in Pennsylvania and Oklahoma.

    Product
    KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-0235-2015·2014-11-12

    Pfizer Recalls TORISEL Kits Due to Diluent Crystallization

    Pfizer is recalling 16,000 TORISEL kits because impurities in the diluent may cause crystals to form after cold storage. The TORISEL drug vials are not affected.

    Product
    TORISEL — TORISEL (TEMSIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1411-2014·2014-07-02

    Bausch & Lomb Recalls Sodium Chloride Ophthalmic Ointment Due to Crystallization

    Bausch & Lomb is recalling 35,253 tubes of Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, due to crystal precipitate formation causing a gritty sensation in the eye.

    Product
    Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1164-2014·2014-03-26

    RX3 Pharmacy Recalls Hydroxyprogesterone Caproate Syringes Due to Crystallization

    RX South LLC is recalling 250 syringes of Hydroxyprogesterone Caproate 250mg/ml due to visible crystals formed by extreme cold during shipping.

    Product
    Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-915-2013·2013-08-28

    Fresenius Kabi Recalls Irinotecan Hydrochloride Injection Due to Crystallization

    Fresenius Kabi USA LLC is recalling 23,672 vials of Irinotecan Hydrochloride Injection because the active ingredient is precipitating in the solution.

    Product
    IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-835-2013·2013-08-14

    Apotex Recalls Piperacillin and Tazobactam Injection Due to Crystallization Risk

    Apotex Corp. is recalling 52,398 vials of Piperacillin and Tazobactam for Injection due to a risk of precipitation or crystallization in IV bags or lines.

    Product
    Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-806-2013·2013-07-24

    Apotex Recalls Piperacillin and Tazobactam Injection Due to Crystallization Risk

    Apotex Corp. is recalling 37,303 vials of Piperacillin and Tazobactam for Injection due to a risk of precipitation or crystallization in IV bags or lines.

    Product
    Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-687-2013·2013-07-17

    Sun Pharmaceutical Recalls Nimodipine Capsules Due to Crystallization

    Sun Pharmaceutical Industries Inc. is recalling Nimodipine Capsules 30 mg due to crystallization of the active ingredient.

    Product
    Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-162-2013·2013-02-20

    Ranbaxy Recalls Lac-Hydrin Lotion Due to Crystallization Texture

    Ranbaxy Inc. is recalling 4,016 bottles of Lac-Hydrin Lotion, 12%, due to a gritty texture caused by crystallization.

    Product
    Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-154-2013·2013-02-13

    Hospira Recalls Carboplatin Injection Vials Due to Visible Crystals

    Hospira is recalling 31,326 vials of Carboplatin Injection due to visible crystals found during inspection. The product is distributed nationwide and in Puerto Rico.

    Product
    CARBOPLATIN — CARBOPLATIN (CARBOPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-153-2013·2013-02-13

    Hospira Recalls Carboplatin Injection Vials Due to Crystallization

    Hospira Inc. is recalling 23,315 vials of Carboplatin Injection due to visible particulates identified as Carboplatin crystals.

    Product
    CARBOPLATIN — CARBOPLATIN (CARBOPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-003-2013·2012-10-10

    Caraco Recalls Nimodipine Capsules Due to Crystallization

    Caraco Pharmaceutical Laboratories is recalling Nimodipine Capsules 30 mg because crystals of the drug were found within the capsule solution.

    Product
    Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories,
    Category
    Drug
    Distribution
    1 state