The Recall Desk

Hazard

Sub Potency recalls

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

What the numbers show

Total
26
Critical
0
Severe
3
Most recent
2026-07-01

Of the 26 sub potency recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (12%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sub potency 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 26

  • ModerateFDA (Drugs)·D-0627-2026·2026-07-01

    Povi-One Povidone-Iodine 10% Topical Drug Recall for Sub Potency

    Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic nationwide due to sub potency. The affected lots have expiration dates ranging from June 2026 to October 2026.

    Product
    POVI-ONE — POVI-ONE (POVIDONE-IODINE 10% TOPICAL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0227-2025·2025-02-26

    Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications

    The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2025·2025-02-26

    Lorazepam tablets recalled due to failed potency and impurity specifications

    The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0569-2024·2024-07-03

    SinuFrin Nasal Decongestant Recalled for Sub-Potency Nationwide

    NeilMed Pharmaceuticals is recalling 20,370 bottles of SinuFrin Quick Relief Decongestant (Lot SD134) nationwide due to sub-potency. No illnesses have been reported.

    Product
    SINUFRIN QUICK RELIEF DECONGESTANT — SINUFRIN QUICK RELIEF DECONGESTANT (SINUFRIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0486-2024·2024-05-15

    Sapropterin Dihydrochloride Powder for Oral Solution Recalled Due to Sub-Potency

    Dr. Reddy's Laboratories is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder 100mg due to sub-potency associated with powder discoloration. The affected lot (T2200352) was distributed nationwide.

    Product
    Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0485-2024·2024-05-15

    Prescription Drug Javygtor Recalled for Sub-Potency and Powder Discoloration

    Dr. Reddy's Laboratories is recalling Javygtor powder packets nationwide due to powder discoloration and sub-potency. The recall affects 17,332 cartons with multiple lot numbers.

    Product
    JAVYGTOR — JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1125-2024·2024-04-03

    Dietary Supplement Recall: TestoFREAK Contains Sub-Potent Zinc Levels

    VRA Formulations is recalling TestoFREAK Maximize Testosterone Dietary Supplement due to sub-potent zinc content. Affected bottles were distributed domestically through internet sales.

    Product
    TestoFREAK Maximize Testosterone Dietary Supplement 60 capsules per dark amber bottle, 100 bottles per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0325-2024·2024-02-21

    Vasopressin Compounded Injectable Syringes Recalled for Sub-Potency Failure

    IntegraDose Compounding Services is recalling Vasopressin injectable syringes because the medication may lose potency before its labeled expiration date, potentially leaving patients with reduced doses.

    Product
    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0103-2024·2023-11-22

    DOP Instant Hand Sanitizer Recalled for Potency Compliance Failures

    Omega & Delta Co., Inc. is recalling specific lots of DOP Instant Hand Sanitizer because they do not meet established potency standards. Some batches are sub-potent or super-potent, potentially affecting antimicrobial effectiveness or causing irritation.

    Product
    DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0040-2024·2023-10-11

    FDA Recalls Subpotent Epinephrine Injectable for Intraocular Surgical Use

    Imprimis NJOF is recalling an epinephrine-lidocaine injectable due to failed potency testing, affecting nationwide distribution. The product was compounded in April 2023 for use during eye surgery.

    Product
    Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1615-2023·2023-10-04

    Pharma Natural Biotin 5000 mcg Dietary Supplement Recalled for Sub-Potency

    Pharma-Natural Inc. is recalling Pharma Natural Biotin 5000 mcg dietary supplement (Lot PN10686, Exp. Date 01/24) distributed in Puerto Rico because FDA testing found the biotin content was below the detection limit.

    Product
    Pharma Natural, Biotin 5000 mcg, Maximum Strength, Dietary Supplement, 30 Tablets
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0771-2023·2023-05-31

    Compounded Tirzepatide Injections Recalled Nationwide Due to Sub-Potency

    Revive Rx is recalling 45 vials of compounded tirzepatide 10 mg/0.5 mL injections nationwide due to sub-potency. Patients should contact their healthcare provider about their medication.

    Product
    Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2023·2023-04-12

    Cyanocobalamin injection vials recalled for failing potency tests

    Accord Healthcare recalled 4,574 cartons of Cyanocobalamin injection (Lot R2200394) nationwide after testing showed the drug was sub-potent and failed to meet strength specifications.

    Product
    Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Dur
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0425-2023·2023-03-22

    Dietary Supplement Sub-Potency Recall: Healthy Sense Daily Multiple with Iron

    Mason Vitamins is recalling Healthy Sense Daily Multiple with Iron dietary supplements because the product contains insufficient levels of Vitamins A, B12, B5, C, and E compared to label claims.

    Product
    Healthy Sense Daily Multiple with Iron, Dietary Supplement, 20 Tablets
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0424-2023·2023-03-22

    Women's Daily Vitamins with Iron Recalled for Sub-Potent Formulation

    Mason Vitamins is recalling People's Choice Women's Daily Vitamins with Iron because the product contains less of five key vitamins than stated on the label. Approximately 224,279 bottles are affected.

    Product
    People's Choice Women's Daily Vitamins with Iron, 30 Tablets, Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0353-2023·2023-03-08

    Prescription Levothyroxine Sodium Tablets Recalled Due to Sub-Potency

    Alvogen is recalling 21,276 bottles of Levothyroxine Sodium Tablets (Lot HE02221, expiration 05/2023) distributed nationwide and in Puerto Rico due to sub-potency.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0077-2023·2022-12-14

    Desmopressin Acetate Tablets Recalled by Manufacturer for Subpotency

    RemedyRepack Inc. is recalling Desmopressin Acetate Tablets due to subpotency. The affected tablets may not provide the intended therapeutic effect.

    Product
    Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1349-2022·2022-08-24

    Azacitidine for Injection Recalled Nationwide for Subpotent Dosage

    Amerisource Health Services is recalling 4,160 vials of Azacitidine for Injection nationwide due to subpotency. The affected vials may contain less than the labeled 100 mg of active ingredient.

    Product
    Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1286-2022·2022-08-03

    Nifedipine WSP Ointment Recalled Due to Potency Variability

    Valor Compounding Pharmacy is recalling Nifedipine WSP 0.2% Ointment due to potency variability. Some batches may be subpotent or superpotent, affecting safety and efficacy.

    Product
    Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0719-2022·2022-03-30

    FDA Recalls NAD+ Injection Due to Sub-Potency and Stability Concerns

    Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide injection vials nationwide due to sub-potency or exceeded reconstitution time.

    Product
    NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceutica
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0722-2022·2022-03-30

    FDA recalls SB-4 compounded injection nationwide for below-strength potency

    SB-4 compounded injection is being recalled nationwide because it contains less active ingredient than labeled. Olympia Compounding Pharmacy initiated this voluntary recall affecting 1,032 vials.

    Product
    SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Man
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1533-2020·2020-09-02

    Hikma Recalls Buprenorphine Hydrochloride Injection Due to Low Potency

    Hikma Pharmaceuticals is recalling 97,890 vials of Buprenorphine Hydrochloride Injection because stability testing revealed the drug was sub-potent.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1251-2019·2019-05-08

    Advanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution

    Advanced Pharma Inc. is voluntarily recalling 560 bags of compounded Hydromorphone 20 mg/100 mL Injectable Solution due to sub-potency. The product was distributed nationwide in the US.

    Product
    HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1011-2019·2019-03-27

    Akorn Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Low Potency

    Akorn Inc is recalling Hydrocortisone and Acetic Acid Otic Solution because routine stability testing revealed the drug was sub-potent.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0377-2019·2019-01-23

    Syntho Pharmaceuticals Recalls EEMT HS Tablets Due to Sub-Potency

    Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT HS tablets due to sub-potency and cGMP violations. The product was distributed nationwide.

    Product
    EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
    Category
    Drug
    Distribution
    0 states