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.

376–400 of 405

  • ModerateFDA (Drugs)·D-430-2013·2013-05-29

    Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency

    King Legacy is recalling Levoxyl (levothyroxine sodium) 175 mcg tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-425-2013·2013-05-29

    Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-310-2013·2013-05-08

    Reckitt Benckiser Recalls Cherry Cepacol Sore Throat Lozenges for Low Benzocaine

    Reckitt Benckiser is recalling Cherry Cepacol Sore Throat Lozenges because the active ingredient, benzocaine, did not meet stability specifications.

    Product
    Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-302-2013·2013-05-08

    Hi-Tech Pharmacal Recalls Subpotent Acetic Acid Otic Solution

    Hi-Tech Pharmacal is recalling 11,472 bottles of Acetic Acid Otic Solution because the product failed potency testing. The recall covers nationwide distribution and Puerto Rico.

    Product
    Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-242-2013·2013-04-10

    West-Ward Recalls Subpotent Ethambutol Hydrochloride Tablets

    West-Ward Pharmaceutical Corp. is recalling 3,061 bottles of Ethambutol Hydrochloride Tablets due to out-of-specification assay results.

    Product
    Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-218-2013·2013-04-03

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,592 bottles of Derma-Smoothe/FS topical oil because the product was found to be subpotent at a 22-month stability timepoint.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-164-2013·2013-02-20

    West-ward Recalls Subpotent Glycopyrrolate Tablets in Ohio

    West-ward Pharmaceutical Corp. voluntarily recalled 1,185 bottles of Glycopyrrolate Tablets, USP, 1 mg, in Ohio due to subpotent drug content.

    Product
    Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-143-2013·2013-02-13

    Actelion Recalls Three Cartons of Subpotent Ventavis Inhalation Solution

    Actelion Pharmaceuticals is recalling three cartons of Ventavis (iloprost) Inhalation Solution due to an out-of-specification assay result indicating the drug was subpotent.

    Product
    Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-090-2013·2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling 5 bottles of Enjuvia tablets due to low assay results. The medication was distributed in Virginia.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-091-2013·2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling specific lots of Enjuvia tablets because they failed potency tests. The affected medication may contain less active ingredient than labeled.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-092-2013·2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling Enjuvia tablets due to low assay results. The recall is limited to a specific lot and expiration date.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-043-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree 24 Hour Severe Acne Clearing System

    Valeant Pharmaceuticals is recalling AcneFree 24 Hour Severe Acne Clearing System cartons because the benzoyl peroxide ingredient is subpotent and the product is mislabeled.

    Product
    AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lot
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-045-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree Benzoyl Peroxide Tubes Nationwide

    Valeant Pharmaceuticals is recalling 619,029 tubes of AcneFree Original Strength Terminator because the product is subpotent and mislabeled.

    Product
    AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-044-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree Oil-Free Acne Cleanser

    Valeant Pharmaceuticals is recalling AcneFree Oil-Free Acne Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.

    Product
    AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-049-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree Acne Pore Cleanser

    Valeant Pharmaceuticals is recalling AcneFree Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.

    Product
    AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-048-2013·2012-11-14

    FDA Recalls Subpotent AcneFree Benzoyl Peroxide Cleanser

    Valeant Pharmaceuticals is recalling AcneFree Severe Maximum Strength Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors.

    Product
    AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-046-2013·2012-11-14

    Valeant Recalls AcneFree Toner Pads Due to Low Salicylic Acid Content

    Valeant Pharmaceuticals is recalling AcneFree Acne Astringent Toner Pads because the salicylic acid ingredient was found to be subpotent.

    Product
    AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-047-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree 3-in-1 Acne Night Repair Foam

    Valeant Pharmaceuticals is recalling AcneFree 3-in-1 Acne Night Repair Foam because the salicylic acid ingredient is subpotent and the label is inaccurate.

    Product
    AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-042-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree 24 Hour Clearing System

    Valeant Pharmaceuticals is recalling AcneFree 24 Hour Clearing System cartons because the benzoyl peroxide active ingredient is subpotent and the labels contain errors regarding inactive ingredients.

    Product
    AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1660-2012·2012-09-05

    Galderma Recalls Subpotent Capex Shampoo Due to Low Fluocinolone Acetonide Levels

    Galderma is recalling 17,160 bottles of Capex Shampoo because the fluocinolone acetonide content is subpotent. The product was distributed nationwide and in Puerto Rico.

    Product
    Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1646-2012·2012-08-22

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil

    Hill Dermaceuticals is recalling 161,064 bottles of Derma-Smoothe/FS scalp oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.

    Product
    Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1647-2012·2012-08-22

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Body Oil

    Hill Dermaceuticals is recalling 111,816 bottles of Derma-Smoothe/FS Body Oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.

    Product
    Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1430-2012·2012-08-08

    Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution for Low Potency

    Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the hydrocodone ingredient was found to be subpotent.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1405-2012·2012-07-11

    Ranbaxy Recalls Subpotent Balnetar Therapeutic Tar Bath Coal Tar Product

    Ranbaxy Inc. is recalling Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5%, because the product failed to meet specifications for coal tar content.

    Product
    Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
    Category
    Drug
    Distribution
    Distributed nationwide