The Recall Desk

Hazard

Undeclared Excipient recalls

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

What the numbers show

Total
10
Critical
3
Severe
4
Most recent
2018-12-26

Of the 10 undeclared excipient recalls we have scored against our rubric, 3 (30%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (40%) 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 undeclared excipient 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.

1–10 of 10

  • CriticalFDA (Drugs)·D-0360-2019·2018-12-26

    Lubrisine eye drops recalled for undeclared colloidal silver and sterility issues

    Results RNA, LLC is recalling Lubrisine eye drops nationwide due to lack of sterility assurance and the presence of undeclared colloidal silver.

    Product
    Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1133-2017·2017-09-13

    ImprimisRx Recalls Timolol Ophthalmic Drops Due to Undeclared Excipient

    ImprimisRx is recalling compounded Timolol ophthalmic drops because they were made with non-pharmaceutical grade PEG 40 Castor Oil due to supplier mislabeling.

    Product
    Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1130-2017·2017-09-13

    ImprimisRx Recalls Curcumin Emulsion Injection Due to Undeclared Excipient

    ImprimisRx is recalling Curcumin Emulsion 10mg/ml Injection vials because non-pharmaceutical grade PEG 40 Castor Oil was used due to supplier mislabeling.

    Product
    Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1131-2017·2017-09-13

    ImprimisRx Recalls Latanoprost Ophthalmic Drops Due to Undeclared Excipient

    ImprimisRx is recalling 19 bottles of compounded Latanoprost ophthalmic drops because they contain non-pharmaceutical grade PEG 40 Castor Oil due to supplier mislabeling.

    Product
    Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1132-2017·2017-09-13

    ImprimisRx Recalls Timolol-Latanoprost Ophthalmic Drops Due to Mislabeling

    ImprimisRx is recalling 16 bottles of compounded Timolol-Latanoprost ophthalmic drops because non-pharmaceutical grade PEG 40 Castor Oil was used due to supplier mislabeling.

    Product
    Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1568-2014·2014-09-03

    Pharmakon Recalls Atropine Sulfate Syringes Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Atropine Sulfate Injection because they contain undeclared benzyl alcohol.

    Product
    Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-1565-2014·2014-09-03

    Pharmakon Recalls Midazolam HCl Vials Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl 2 mg/ml vials because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1566-2014·2014-09-03

    Pharmakon Recalls Midazolam IV Bags Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl IV bags because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1567-2014·2014-09-03

    Pharmakon Recalls Glycopyrrolate Syringes for Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling 200 pre-filled syringes of Glycopyrrolate 0.2 mg/ml because they contain undeclared benzyl alcohol.

    Product
    Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
    Category
    Drug
    Distribution
    4 states