The Recall Desk

Hazard

Potency Deviation recalls

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

What the numbers show

Total
19
Critical
0
Severe
1
Most recent
2026-05-06

Of the 19 potency deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) 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 deviation 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.

1–19 of 19

  • ModerateFDA (Drugs)·D-0526-2026·2026-05-06

    Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results

    Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.

    Product
    ALENDRONATE SODIUM — ALENDRONATE SODIUM (ALENDRONATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2025·2025-03-26

    FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation

    Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0131-2025·2024-12-18

    Levothyroxine Sodium 100 mcg Tablets Recalled for Potency Deviations Nationwide

    Mylan Institutional is recalling 2,835 cartons of Levothyroxine Sodium 100 mcg tablets nationwide due to potency deviations—some tablets may be underdosed while others may be overdosed.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0473-2024·2024-05-01

    Cloderm Cream Recalled for Manufacturer Quality Assurance Program Discontinuation

    EPI Health is recalling Cloderm cream due to discontinuation of the manufacturer's quality assurance program. This may result in products that do not meet specifications for identity, strength, purity, or quality.

    Product
    Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0004-2023·2022-10-05

    Esomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency

    Sun Pharmaceutical is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg nationwide due to superpotency findings. Lot AC14299 (expiration 12/2022) tested out of specification for drug assay at the 12-month stability timepoint.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2022·2022-07-06

    Tegsedi Injection Recalled for Higher-Than-Labeled Content

    Akcea Therapeutics recalls certain Tegsedi (inotersen) Injection lots due to higher-than-labeled active ingredient content. Affected lots were distributed in Kentucky.

    Product
    Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0285-2022·2021-12-22

    Telmisartan and Hydrochlorothiazide Tablets Recalled for Superpotency

    Torrent Pharma Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets USP 40 mg/12.5 mg due to superpotency. The affected batch (BZ74G001, expiring 12/2021) contains approximately 27,312 bottles distributed nationwide.

    Product
    Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1215-2018·2018-10-03

    Baxter Recalls Levofloxacin Injection Bags Due to High Potency

    Baxter Healthcare is recalling 523,896 bags of Levofloxacin Injection in 5% Dextrose because the drug concentration was higher than specified.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1034-2018·2018-08-15

    Baxter Recalls Levofloxacin Injection Due to High Potency Levels

    Baxter Healthcare is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification potency results.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1035-2018·2018-08-15

    Baxter Recalls Levofloxacin Injection Due to High Potency Levels

    Baxter Healthcare is recalling specific lots of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0130-2017·2016-11-16

    Wells Pharmacy Recalls Estradiol Pellets Due to Potency Issues

    Wells Pharmacy Network is recalling Estradiol 3 mg Pellets because they may be superpotent or subpotent. Consumers should stop using the product.

    Product
    Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0132-2017·2016-11-16

    Wells Pharmacy Recalls Estradiol Pellets Due to Potency Issues

    Wells Pharmacy Network is recalling Estradiol 12.5 mg Pellets because they may be superpotent or subpotent. Consumers should stop using the product.

    Product
    Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1470-2016·2016-08-31

    Teva Recalls Amoxicillin Oral Suspension Due to Potency Issues

    Teva North America is recalling Amoxicillin for Oral Suspension because stability testing showed the drug was superpotent.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0030-2016·2015-10-21

    Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay Results

    Ohm Laboratories is recalling specific batches of Leader Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0028-2016·2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets Due to Potency Issues

    Ohm Laboratories is recalling specific batches of loratadine orally disintegrating tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0037-2016·2015-10-21

    Sunmark Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Sunmark loratadine tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1239-2014·2014-04-30

    GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count N
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1390-2012·2012-06-27

    Hospira Recalls Magnesium Sulfate Injection Due to High Potency

    Hospira, Inc. is recalling 164,568 containers of Magnesium Sulfate in Water for Injection because the product contained higher levels of magnesium sulfate than specified.

    Product
    MAGNESIUM SULFATE IN WATER — MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE IN WATER)
    Category
    Drug
    Distribution
    Distributed nationwide