The Recall Desk

Hazard

Potency Variation recalls

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

What the numbers show

Total
13
Critical
0
Severe
3
Most recent
2024-12-18

Of the 13 potency variation 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 (23%) 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 potency variation 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.

1–13 of 13

  • HighFDA (Drugs)·D-0124-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled for Potency Variation and Dosage Failures

    Viatris Inc. is recalling 42,331 bottles of Levothyroxine Sodium Tablets 50 mcg distributed nationwide due to potency failures resulting in both superpotent and subpotent tablets.

    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
  • LowFDA (Drugs)·D-0119-2021·2020-12-09

    Teligent Pharma Recalls Clobetasol Propionate Ointment Due to Potency Issues

    Teligent Pharma is recalling Clobetasol Propionate Ointment 0.05% because some tubes have superpotent or subpotent assay results.

    Product
    Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0854-2018·2018-06-20

    PharMEDium Recalls Hydromorphone Syringes Due to Potency Issues

    PharMEDium Services is recalling 2,800 hydromorphone syringes nationwide because some units were found to be superpotent or subpotent.

    Product
    HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0150-2018·2018-01-10

    Pfizer Recalls Diphenoxylate and Atropine Tablets Due to Potency Variations

    Pfizer is recalling specific lots of diphenoxylate hydrochloride and atropine sulfate tablets because weight variations caused some tablets to be sub-potent or super-potent.

    Product
    DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0151-2018·2018-01-10

    Pfizer Recalls Zoloft Tablets Due to Weight Variations

    Pfizer is recalling 1,972 bottles of Zoloft 25 mg tablets because weight variations caused some tablets to be sub or super potent.

    Product
    Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1243-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Quality Failures

    GlaxoSmithKline is recalling Nicorette 4 mg lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1242-2014·2014-04-30

    Nicorette Lozenges Recalled for Thickness and Potency Failures

    GlaxoSmithKline is recalling Nicorette 2 mg lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1246-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1238-2014·2014-04-30

    GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1240-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette 4 mg lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1244-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette and Nicoderm CQ Products for Quality Failures

    GlaxoSmithKline is recalling specific lots of Nicorette and Nicoderm CQ products because the lozenges failed quality specifications, including being overly thick, soft, and having incorrect potency.

    Product
    Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1245-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette Lozenges Mini because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    NICORETTE — NICORETTE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    Distributed nationwide