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.

51–66 of 66

  • ModerateFDA (Drugs)·D-0694-2017·2017-05-10

    P & L Development Recalls Subpotent Diphenhydramine HCl Allergy Softgels

    P & L Development is recalling 369,012 cartons of diphenhydramine HCl allergy softgels sold under multiple brands due to low potency test results.

    Product
    Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Aller
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0675-2017·2017-04-26

    InnovaGel Recalls Subpotent Dye Free Allergy Softgel Gelatin Capsules

    InnovaGel is voluntarily recalling Dye Free Allergy Softgel Gelatin Capsules because they are subpotent. The affected product was distributed in New York.

    Product
    Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0213-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in both superpotent and subpotent doses.

    Product
    Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0212-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate sublingual tablets because they failed content uniformity specifications, resulting in tablets that are either superpotent or subpotent.

    Product
    Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1605-2014·2014-10-01

    Qualitest Recalls Subpotent Methylprednisolone Tablets Due to Stability Issues

    Qualitest Pharmaceuticals is recalling specific lots of Methylprednisolone 4 mg tablets because they may be subpotent due to a 6-month stability time point issue.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66207-001·2013-10-30

    Hi-Tech Pharmacal Recalls Subpotent Giltuss and Exactuss Cough Medicines

    Hi-Tech Pharmacal is recalling specific lots of Giltuss and Exactuss cough and cold medicines because they contain less phenylephrine than labeled.

    Product
    GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 0071
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-66402-001·2013-10-30

    Tolmar Recalls Subpotent Ketoconazole Shampoo Nationwide

    Tolmar Inc. is voluntarily recalling 391,055 bottles of 2% Ketoconazole Shampoo nationwide because the product was found to be subpotent.

    Product
    Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-897-2013·2013-08-28

    Stayma Recalls Subpotent NataChew Multi-Vitamin Tablets

    Stayma Consulting Service is recalling specific lots of NataChew multi-vitamin tablets because they contain subpotent levels of beta carotene (Vitamin A).

    Product
    NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-895-2013·2013-08-28

    FDA Recalls Duet DHA 400 for Subpotent Beta Carotene

    Stayma Consulting Service is recalling Duet DHA 400 multi-vitamin and Omega-3 products because they contain subpotent levels of beta carotene (Vitamin A).

    Product
    Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 763
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-896-2013·2013-08-28

    Stayma Recalls Duet DHA 400 ec Due to Subpotent Beta Carotene

    Stayma Consulting Service is recalling specific lots of Duet DHA 400 ec because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-603-2013·2013-06-26

    Hi-Tech Pharmacal Recalls Subpotent HydrOXYzine Hydrochloride Oral Solution

    Hi-Tech Pharmacal is recalling specific lots of HydrOXYzine Hydrochloride Oral Solution because the product failed stability testing and may be subpotent.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-168-2013·2013-03-06

    Pacira Recalls Subpotent EXPAREL Bupivacaine Injectable Vials

    Pacira Pharmaceuticals is recalling 324 vials of EXPAREL (bupivacaine liposome injectable suspension) because the product is subpotent.

    Product
    EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-101-2013·2013-01-02

    Lloyd Inc. of Iowa Recalls Subpotent Levothroid Levothyroxine Sodium Tablets

    Lloyd Inc. of Iowa is recalling specific lots of Levothroid (levothyroxine sodium) tablets because they are subpotent and have a 9-month stability interval.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-100-2013·2013-01-02

    Lloyd Inc. Recalls Subpotent Thyro-Tab 0.050 mg. Tablets

    Lloyd Inc. of Iowa is recalling specific lots of Thyro-Tab 0.050 mg. tablets because they are subpotent and have a 9-month stability interval.

    Product
    Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-104-2013·2013-01-02

    Alara Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Issues

    Alara Pharmaceutical is recalling 7,432 bottles of Levothyroxine Sodium Tablets because the product is subpotent and has stability issues.

    Product
    Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-103-2013·2013-01-02

    Lloyd Inc. of Iowa Recalls Subpotent Levothroid 75 mcg Tablets

    Lloyd Inc. of Iowa is recalling 16,548 bottles of Levothroid 75 mcg tablets because the product is subpotent and has a 9-month stability interval.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide