The Recall Desk

Hazard

Subpotent recalls

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

What the numbers show

Total
66
Critical
2
Severe
8
Most recent
2026-07-22

Of the 66 subpotent recalls we have scored against our rubric, 2 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (12%) 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 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 66

  • ModerateFDA (Drugs)·D-0688-2026·2026-07-22

    CAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient

    CAREone Earwax Removal Drops (Carbamide Peroxide 6.5%) are recalled because the product contains significantly reduced active ingredient (~0.6% vs. expected ~6–7%) and low pH, making it ineffective.

    Product
    CAREONE EARWAX REMOVAL DROPS — CAREONE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0593-2026·2026-06-24

    Compounded vasopressin syringes recalled as subpotent by IntegraDose Compounding Services

    Vasopressin 2 Units/2 mL in 0.9% sodium chloride syringes from IntegraDose Compounding Services are being recalled as a subpotent drug. 287 units are affected.

    Product
    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2026·2026-04-22

    glo Skin Beauty Remedy Gel recalled as a subpotent hydrocortisone product

    Remedy Gel, hydrocortisone 1%, distributed by glo Skin Beauty is being recalled because the product is subpotent. The action covers 1,060 bottles.

    Product
    Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2026·2026-04-22

    Avantor magnesium chloride active pharmaceutical ingredient recalled as subpotent

    Avantor Performance Materials is recalling one lot of bulk Magnesium Chloride 6-Hydrate active pharmaceutical ingredient because the material is subpotent. 36 bottles are affected.

    Product
    Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2026·2026-04-22

    Skin Rehab calming hydrocortisone balm recalled as a subpotent drug

    Skin Rehab Calming Skin Gel Hydrocortisone Balm, hydrocortisone 1%, is being recalled because the product is subpotent. The action covers 2,895 bottles.

    Product
    Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0482-2026·2026-04-22

    Rhonda Allison calming skin gel recalled as a subpotent hydrocortisone product

    Essential Calming Skin Gel containing 1% hydrocortisone is being recalled because the product is subpotent. The action covers 299 bottles.

    Product
    Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0445-2026·2026-04-15

    Teva isotretinoin 30 mg capsules recalled as superpotent and subpotent

    Teva is recalling three lots of Isotretinoin Capsules, USP, 30 mg because the product was found to be superpotent and subpotent. 21,984 packages are affected.

    Product
    ISOTRETINOIN — ISOTRETINOIN (ISOTRETINOIN)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0446-2026·2026-04-15

    Teva isotretinoin 40 mg capsules recalled as superpotent and subpotent

    Teva is recalling three lots of Isotretinoin Capsules, USP, 40 mg because the product was found to be superpotent and subpotent. 8,376 packages are affected.

    Product
    ISOTRETINOIN — ISOTRETINOIN (ISOTRETINOIN)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0294-2026·2026-01-28

    Bulk thyroid drug substance recalled as subpotent from one lot

    Specialty Process Labs is recalling one lot of Thyroid, USP bulk drug substance because it is subpotent.

    Product
    Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0295-2026·2026-01-28

    Icosapent ethyl capsules recalled as subpotent after capsule contents leaked

    Zydus Pharmaceuticals is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram, because oxidation caused by leakage of the capsule contents has left them subpotent.

    Product
    Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0237-2026·2025-12-24

    Cisatracurium 200 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 28,660 vials of Cisatracurium Besylate Injection, 200mg/20mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2026·2025-12-24

    Cisatracurium 10 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 52,340 vials of Cisatracurium Besylate Injection, 10 mg/5 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2026·2025-12-24

    Cisatracurium 20 mg multiple-dose vials recalled after subpotent assay results

    Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0219-2026·2025-12-17

    Varenicline tablets recalled after an assay value fell below specification

    Dr. Reddy's Laboratories is recalling 4,800 bottles of Varenicline Tablets, 1mg, after the assay value for the affected lot fell below the specification limit at nine-month stability testing.

    Product
    VARENICLINE TARTRATE — VARENICLINE TARTRATE (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0035-2026·2025-10-29

    Alcohol prep pads recalled from one lot as a subpotent drug

    Medline is recalling 222,800 alcohol prep pads from one lot because the product is subpotent.

    Product
    Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0015-2026·2025-10-22

    Compounded oxytocin bags recalled after testing found no oxytocin present

    IntegraDose Compounding Services is recalling 853 bags of Oxytocin 30 Units/500 mL in 0.9% sodium chloride after testing revealed there was no oxytocin in the IV bag.

    Product
    Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0535-2025·2025-07-30

    Compounded epinephrine lidocaine vials returned subpotent assay results in stability testing

    Epinephrine Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL vials compounded by Imprimis NJOF are being recalled because of subpotent assay results during stability testing. 6,880 vials affected.

    Product
    Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0536-2025·2025-07-30

    Compounded quadruple ophthalmic solution returned subpotent assay results in stability testing

    A compounded Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solution is being recalled because of subpotent assay results during stability testing. 2,890 vials are affected.

    Product
    Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0521-2025·2025-07-23

    Levothyroxine sodium 100 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 100 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 9,739 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0519-2025·2025-07-23

    Levothyroxine sodium 25 microgram bottles of 1000 assayed below specification

    Levothyroxine Sodium Tablets, USP 25 mcg in 1000-count bottles from Accord Healthcare are being recalled because the product is subpotent. 2,352 bottles are affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0520-2025·2025-07-23

    Levothyroxine sodium 50 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 50 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 54,227 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0524-2025·2025-07-23

    Levothyroxine sodium 175 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 175 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 2,344 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide