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.

251–275 of 405

  • LowFDA (Drugs)·D-1109-2017·2017-08-23

    Linde Eckstein Recalls Make Up Perfect SPF 10 Liquid Make-up

    Linde Eckstein Gmbh + Co KG is recalling Make Up Perfect dark tan SPF 10 liquid make-up because the SPF 10 protection claim cannot be guaranteed.

    Product
    Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0868-2017·2017-06-07

    Sandoz Recalls Subpotent Amoxicillin and Clavulanate Potassium Tablets

    Sandoz Inc is recalling 4,464 bottles of Amoxicillin and Clavulanate Potassium tablets found to be subpotent in clavulanic acid.

    Product
    AMOXICILLIN AND CLAVULANATE POTASSIUM — AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0674-2017·2017-04-26

    InnovaGel Recalls Subpotent Diphenhydramine HCl Softgel Capsules

    InnovaGel is recalling approximately 7.9 million subpotent Diphenhydramine HCl 25 mg softgel capsules distributed in New York.

    Product
    Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0647-2017·2017-04-12

    Fresenius Kabi Recalls Subpotent Fluphenazine Decanoate Injection Vials

    Fresenius Kabi USA is recalling 118,224 vials of Fluphenazine Decanoate Injection because the drug was found to be subpotent.

    Product
    Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0516-2017·2017-03-22

    Pfizer Recalls PROTONIX IV Vials for Subpotent Potency

    Pfizer is recalling 582,165 vials of PROTONIX IV (pantoprazole sodium) because the drug failed potency testing at the 6-month stability time point.

    Product
    PROTONIX — PROTONIX (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0454-2017·2017-02-08

    Ecolab Recalls Subpotent Chlorhexidine Gluconate Foam Solution

    Ecolab is recalling 427 bottles of Endure 400 Scrub-Stat foam solution because the product was found to be subpotent.

    Product
    Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 5510
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0433-2017·2017-01-25

    Novum Pharma Recalls Subpotent Novacort Gel Sample Packets

    Novum Pharma is recalling Novacort Gel sample packets because the pramoxine hydrochloride content was found to be out of specification.

    Product
    Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0436-2017·2017-01-25

    Town and Country Recalls Subpotent HCG Vials Due to Failed Potency

    Town and Country Compounding is recalling 101 vials of HCG because potency testing showed 74%, below the required 80-125% range.

    Product
    HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0237-2017·2017-01-04

    Cipher Pharmaceuticals Recalls Subpotent Inova Benzoyl Peroxide Pads

    Cipher Pharmaceuticals is recalling 216 boxes of Inova benzoyl peroxide pads due to subpotent drug levels. The product was distributed in Arizona, Colorado, and Ohio.

    Product
    INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-0172-2017·2016-12-14

    West-Ward Recalls Sodium Ferric Gluconate Injection Due to Low Iron Content

    West-Ward Pharmaceuticals is recalling 5,142 shelf-packs of Sodium Ferric Gluconate Complex in Sucrose Injection because stability testing revealed the product had lower iron content than specified.

    Product
    SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE — SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0126-2017·2016-11-16

    FDA Recalls Wells Pharmacy Testosterone and Anastrozole Pellets

    Wells Pharmacy Network is recalling compounded Testosterone 200 mg/Anastrozole 9 mg Pellets because they are superpotent or subpotent.

    Product
    Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0134-2017·2016-11-16

    Taro Recalls Kamedis Dandruff Care Kits Due to Low Active Ingredient

    Taro Pharmaceuticals is recalling 17,100 kits of Kamedis Bio-Herbal Dandruff Care System because the active ingredient, zinc pyrithione, was found to be subpotent.

    Product
    Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Bot
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0124-2017·2016-11-09

    Akorn Recalls Subpotent Sodium Chloride Ophthalmic Solution

    Akorn Inc. is recalling 29,972 bottles of 5% Sodium Chloride Ophthalmic Solution because the product concentration is less than the labeled amount.

    Product
    Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0119-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1.5/30 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers specific lots distributed nationwide and in Puerto Rico.

    Product
    Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST P
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0120-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess 1/20 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers 393,981 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARM
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0123-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess 24 FE 1.5/30 Oral Contraceptives

    Par Pharmaceutical is recalling Gildess 24 FE 1.5/30 oral contraceptives because the ethinyl estradiol component is subpotent. The recall covers 44,127 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0122-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1.5/30 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1.5/30 tablets because they may contain subpotent levels of ethinyl estradiol.

    Product
    Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0121-2017·2016-11-09

    Par Pharmaceutical Recalls Subpotent Gildess FE 1/20 Oral Contraceptive Tablets

    Par Pharmaceutical is recalling Gildess FE 1/20 tablets because the ethinyl estradiol component is subpotent. The recall covers 822,009 tablets distributed nationwide and in Puerto Rico.

    Product
    Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHAR
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0096-2017·2016-10-19

    Hospira Recalls Marcaine Injection Due to Sterility and Potency Issues

    Hospira is recalling 15 vials of Marcaine 0.25% injection because a glass defect allowed water to enter, compromising sterility and reducing drug potency.

    Product
    MARCAINE — MARCAINE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1474-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1478-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1477-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1475-2016·2016-09-07

    Clinique Moisturizer Recalled for Low Sunscreen Ingredient Levels

    Clinique International is recalling Moisture Surge Tinted Moisturizer SPF 15 because two active sunscreen ingredients are below required levels.

    Product
    CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)
    Category
    Drug
    Distribution
    Distributed nationwide