The Recall Desk

Hazard

Stability Data Gap recalls

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

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2023-06-07

Of the 7 stability data gap recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 stability data gap 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.

1–7 of 7

  • ModerateFDA (Drugs)·D-0819-2023·2023-06-07

    Levofloxacin Oral Solution Recalled Due to Manufacturing Compliance Issues

    Akorn, Inc. recalled all lots of Levofloxacin Oral Solution due to the company going out of business and being unable to continue required stability studies. Patients currently taking this medication should contact their healthcare provider.

    Product
    Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0703-2022·2022-03-30

    Hydrocortisone Butyrate Lotion Recalled for cGMP Deviations

    Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its stability study program.

    Product
    Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0679-2022·2022-03-30

    Diclofenac Sodium Topical Solution recalled by Teligent Pharma

    Teligent Pharma is recalling all unexpired batches of Diclofenac Sodium Topical Solution 1.5% due to current good manufacturing practice (cGMP) deviations related to discontinuation of the firm's stability study program.

    Product
    Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0523-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Tacrolimus USP Due to Stability Data Gaps

    American Pharmaceutical Ingredients is recalling specific lots of Tacrolimus USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0538-2018·2018-02-28

    FDA Recalls Vitamin B12 Compounding Ingredient Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Cyanocobalamin USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 4832
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0530-2018·2018-02-28

    FDA Recalls Tretinoin USP for Prescription Compounding Due to Stability Data Gaps

    American Pharmaceutical Ingredients LLC is recalling Tretinoin USP for prescription compounding because the manufacturer lacked stability data and controls to support the assigned expiration dates.

    Product
    Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Medroxyprogesterone Acetate Due to Stability Data Gaps

    American Pharmaceutical Ingredients is recalling 12,000 grams of Medroxyprogesterone Acetate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration date.

    Product
    Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8
    Category
    Drug
    Distribution
    Distributed nationwide