The Recall Desk

Hazard

Subpotent Drug recalls

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

What the numbers show

Total
405
Critical
19
Severe
137
Most recent
2026-09-02

Of the 405 subpotent drug recalls we have scored against our rubric, 19 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 137 (34%) 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 subpotent drug 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.

326–350 of 405

  • LowFDA (Drugs)·D-1081-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling 5,352 bottles of Olanzapine 20 mg tablets because the drug was found to be subpotent.

    Product
    Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2015·2015-04-22

    Actavis Recalls Subpotent Flurandrenolide Tape Products Nationwide

    Actavis is recalling Flurandrenolide Tape products because the active ingredient is subpotent. The recall covers 78,522 cartons distributed in the U.S. and U.K.

    Product
    Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144. Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 i
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0433-2015·2015-04-15

    Hospira Recalls MitoXANTRONE Injection Due to Stability Failures

    Hospira Inc. is recalling MitoXANTRONE Injection vials because the product failed stability specifications, resulting in subpotent medication and out-of-specification impurities.

    Product
    MITOXANTRONE — MITOXANTRONE (MITOXANTRONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0406-2015·2015-03-11

    Actavis Recalls Vancomycin Hydrochloride Capsules Due to Subpotent Drug

    Actavis Inc. is voluntarily recalling 29,405 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug was found to be subpotent.

    Product
    Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0396-2015·2015-03-11

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc. is voluntarily recalling 51,472 cartons of Vancomycin Hydrochloride Capsules, USP, 125 mg, because the drug is subpotent.

    Product
    Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0401-2015·2015-03-11

    AvKARE Recalls Subpotent Quinapril Tablets Due to Low Dosage

    AvKARE Inc. is voluntarily recalling 214 unit dose packs of Quinapril 5 mg tablets nationwide because the medication is subpotent.

    Product
    Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0402-2015·2015-03-11

    AvKARE Recalls Subpotent Quinapril Tablets Due to Low Drug Content

    AvKARE Inc. is voluntarily recalling 431 unit dose packs of Quinapril Tablets USP, 40 mg, because the medication was found to be subpotent.

    Product
    Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0326-2015·2014-12-31

    Neolpharma Recalls Subpotent Alprazolam Tablets Nationwide

    Neolpharma, Inc. is voluntarily recalling 12,310 bottles of 0.25 mg alprazolam tablets nationwide because the medication was found to be subpotent.

    Product
    ALPRAZOLAM — ALPRAZOLAM (ALPRAZOLAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2015·2014-12-03

    Baxter Recalls Heparin Sodium Injection Due to Low Potency

    Baxter Healthcare is recalling Heparin Sodium in Sodium Chloride Injection because the raw material was found to have low potency.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0233-2015·2014-11-05

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc. is voluntarily recalling 46,676 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug is subpotent.

    Product
    Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2015·2014-11-05

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc is voluntarily recalling 26,663 cartons of Vancomycin Hydrochloride Capsules because the drug was found to be subpotent.

    Product
    Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0040-2015·2014-10-29

    American Family Pharmacy Recalls Subpotent Aspirin Tablets

    American Family Pharmacy is recalling 4.2 million bottles of Assured Aspirin 81 mg tablets because they failed to meet USP specifications for potency and uniformity.

    Product
    Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0025-2015·2014-10-22

    Valeant Recalls Subpotent Hydrocortisone Butyrate Cream 0.1% Tubes

    Valeant Pharmaceuticals is recalling 34,218 tubes of Hydrocortisone Butyrate Cream 0.1% because the product failed stability testing for potency and preservative levels.

    Product
    Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2015·2014-10-22

    Valeant Recalls Subpotent Locoid Hydrocortisone Butyrate Cream Tubes

    Valeant Pharmaceuticals is recalling 1,663 tubes of Locoid cream because the active ingredient and preservatives were subpotent at the 18-month stability test point.

    Product
    Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0014-2015·2014-10-15

    Bracco Recalls E-Z-GAS Antacid Due to Subpotent Drug Levels

    Bracco Diagnostic Inc is recalling E-Z-GAS antacid packets because routine stability testing found the drug to be subpotent.

    Product
    E-Z-GAS — E-Z-GAS (ANTACID/ANTIFLATULENT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1609-2014·2014-10-01

    Apotex Recalls Olanzapine Tablets Due to Subpotent Drug Levels

    Apotex Corp. is recalling Olanzapine Orally Disintegrating Tablets 5 mg because testing showed the drug levels were below specification.

    Product
    Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1536-2014·2014-08-20

    Bracco Recalls E-Z-HD Barium Sulfate Due to Low Potency

    Bracco Diagnostic Inc is recalling E-Z-HD (barium sulfate) bottles because routine stability testing revealed low pH and assay results.

    Product
    E-Z-HD — E-Z-HD (BARIUM SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1386-2014·2014-06-25

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc is recalling 6,913 packages of Vancomycin Hydrochloride Capsules because the drug is subpotent. The recall covers distribution across the United States.

    Product
    Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1359-2014·2014-06-11

    CareFusion Recalls Surgical Scrub Brushes With Low Iodine Levels

    CareFusion is recalling surgical scrub brushes because the available iodine content is lower than stated on the label.

    Product
    CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1360-2014·2014-06-11

    CareFusion Recalls Surgical Scrub Brushes With Low Iodine Levels

    CareFusion is recalling surgical scrub brushes because the available iodine content is lower than stated on the label.

    Product
    CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1254-2014·2014-04-30

    P&L Developments Recalls Subpotent Day Time Cold & Flu OTC Drug

    P&L Developments, LLC is recalling 2,500,510 bottles of Day Time Cold & Flu because the phenylephrine component is subpotent.

    Product
    Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1175-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.

    Product
    Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1181-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Ear Drops

    Hill Dermaceuticals is recalling 13,591 bottles of Fluocinolone Acetonide 0.01% Oil Ear Drops because routine testing found the active ingredient to be subpotent.

    Product
    SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1176-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS topical oil because the active ingredient was found to be subpotent during routine testing.

    Product
    DERMA-SMOOTHE/FS — DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1179-2014·2014-04-02

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 4,142 bottles of Fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.

    Product
    SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04
    Category
    Drug
    Distribution
    Distributed nationwide