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.

26–50 of 66

  • HighFDA (Drugs)·D-0518-2025·2025-07-23

    Levothyroxine sodium 25 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 25 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 82,159 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0522-2025·2025-07-23

    Levothyroxine sodium 112 microgram tablets assayed below the approved specification

    Levothyroxine Sodium Tablets, USP 112 mcg from Accord Healthcare are being recalled because the product is subpotent, with an assay below the approved specification. 4,896 bottles affected.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    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
  • ModerateFDA (Drugs)·D-0458-2025·2025-06-11

    Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content

    Spectrum Advanced Gel Hand Sanitizer (70% ethyl alcohol, 8 FL OZ) has been recalled nationwide because affected batches contain cloudy appearance and test below the claimed 70% alcohol concentration, making them less effective.

    Product
    HAND SANITIZER — HAND SANITIZER (ETHYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Tablets

    Mylan Institutional recalls levothyroxine sodium tablets (lot 3115707) due to subpotent and superpotent tablets. The product was distributed nationwide. Consult your healthcare provider.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2025·2024-12-18

    FDA Recalls Levothyroxine Sodium Tablets for Potency Variation

    Mylan Institutional recalls 690 cartons of Levothyroxine Sodium 150 mcg tablets nationwide due to potency variation. Some units may be subpotent or superpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0633-2024·2024-08-21

    Hydrocortisone & Acetic Acid Otic Solution Recalled for Potency and Impurity Failures

    Taro Pharmaceuticals recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution (lot AD12890) due to failed impurity specifications and lower-than-established active ingredient levels during stability testing.

    Product
    Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0043-2024·2023-10-25

    Ophthalmic Solution Recalled Due to Subpotent Ketorolac Levels

    MYDRIATIC-4 ophthalmic solution is being recalled because ketorolac levels fell below the required 90-110% specification. The product was distributed to physician offices nationwide.

    Product
    MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0891-2023·2023-07-05

    Amphotericin B Liposome Injection Recalled for Subpotency Nationwide

    Sun Pharmaceutical recalled Amphotericin B Liposome for Injection due to subpotent drug content. The recall involved 12,960 vials distributed nationwide across the United States.

    Product
    Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0174-2023·2023-02-01

    Clobetasol Propionate Cream recalled due to subpotent drug

    Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% nationwide because stability testing revealed insufficient active ingredient in the affected lot.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0127-2023·2023-01-25

    Injectable Anesthetic Sensorcaine Recalled for Subpotent Epinephrine

    Sensorcaine injectable anesthetic is being recalled because testing showed the epinephrine component is below the required potency level. No illnesses or injuries have been reported.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1342-2022·2022-08-24

    Hand sanitizer recalled for methanol contamination and insufficient ethanol

    Medek LLC is recalling M Hand Sanitizer due to FDA analysis finding methanol contamination and ethanol levels below label claims. Approximately 256 bottles distributed in Texas.

    Product
    M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1148-2022·2022-06-22

    Premium Nature Hand Sanitizer Recalled for Subpotent Ethanol Content

    AMS Packaging is recalling Premium Nature Instant Hand Sanitizer nationwide because FDA analysis found some bottles contain less ethanol than labeled.

    Product
    Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0863-2022·2022-05-18

    FDA recalls Nandrolone Decanoate compounding ingredient for subpotency nationwide

    Fagron, Inc. recalls 53 containers of Nandrolone Decanoate compounding ingredient due to subpotency. The product was distributed nationwide.

    Product
    Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0766-2022·2022-04-20

    Cyanocobalamin Injection Recalled for Subpotent Drug - Out of Specification Assay

    Aurobindo Pharma USA Inc. is recalling 433,809 vials of Cyanocobalamin injection nationwide because assay testing showed the drug is subpotent, containing less than the specified 1,000 mcg/mL of active ingredient. Affected lots with specific expiration dates from September 2022 to April 2023 are identified for recall.

    Product
    CYANOCOBALAMIN — CYANOCOBALAMIN (CYANOCOBALAMIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0569-2022·2022-03-02

    Norepinephrine Bitartrate IV Bags Recalled for Subpotency

    BayCare Central Pharmacy is recalling 1,157 bags of norepinephrine bitartrate 16 mg in 250 mL saline solution distributed in Florida because the drug is subpotent—meaning it contains less active ingredient than labeled.

    Product
    Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0024-2022·2021-10-27

    AirDuo Digihaler inhalation powder subpotent drug recall

    Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some batches do not deliver the labeled amount of salmeterol, a critical active ingredient for asthma and COPD control.

    Product
    AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0289-2021·2021-03-10

    Sun Pharma Recalls Subpotent Cequa Cyclosporine Ophthalmic Solution Vials

    Sun Pharmaceutical Industries is recalling Lot 10007 of Cequa (cyclosporine) ophthalmic solution because the product is subpotent. The recall covers 37,400 cartons distributed nationwide and in Australia.

    Product
    CEQUA — CEQUA (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0066-2021·2020-11-11

    Jubilant Recalls Subpotent Olanzapine Orally Disintegrating Tablets Nationwide

    Jubilant Cadista Pharmaceuticals is voluntarily recalling 23,616 blister packs of Olanzapine Orally Disintegrating Tablets, 5 mg, because the product was found to be subpotent.

    Product
    Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1607-2020·2020-09-23

    RLC Labs Recalls WP Thyroid Tablets Due to CGMP Deviations

    RLC Labs Inc. is recalling WP Thyroid tablets because they were manufactured under conditions found to be subpotent.

    Product
    WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Tablets, NDC 64727-5550-4; c) 60 Tablets, NDC 64727-5550-5; d) 90 Tablets, NDC 64727-5550-6; e) 100 Tablets, NDC 64727-5550-1; Rx only, Manufactured by: RLC Labs Pho
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1411-2020·2020-08-05

    Hand Sanitizer Recalled for Subpotent Alcohol and High pH Levels

    World Event Promotions, LLC is recalling Handese Advanced Instant Hand Sanitizer because the product was found to be subpotent and has high pH levels.

    Product
    Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0780-2020·2020-01-22

    Letco Medical Recalls Subpotent Estriol USP Micronized Drug Products

    Letco Medical LLC is voluntarily recalling subpotent Estriol USP Micronized products distributed in the US and internationally.

    Product
    Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0833-2018·2018-05-30

    Milbar Recalls Subpotent Zoma Shampoo Bottles

    Milbar Laboratories is recalling 1,348 bottles of Zoma Shampoo because the product was found to be subpotent.

    Product
    Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0832-2018·2018-05-30

    Milbar Recalls Subpotent Coal Tar Shampoo for Hair and Body

    Milbar Laboratories is voluntarily recalling 952 bottles of T Shampoo For Hair and Body because the product is subpotent.

    Product
    T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0575-2018·2018-01-31

    Advanced Pharma Recalls Subpotent Magnesium Sulfate IV Bags

    Advanced Pharma Inc. is recalling 25 bags of Magnesium Sulfate IV solution in Texas due to subpotent product.

    Product
    MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10
    Category
    Drug
    Distribution
    1 state