The Recall Desk

Hazard

Potency Failure recalls

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

What the numbers show

Total
30
Critical
0
Severe
4
Most recent
2026-04-22

Of the 30 potency failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (13%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all potency failure 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.

1–25 of 30

  • ModerateFDA (Drugs)·D-0482-2026·2026-04-22

    Rhonda Allison calming skin gel recalled as a subpotent hydrocortisone product

    Essential Calming Skin Gel containing 1% hydrocortisone is being recalled because the product is subpotent. The action covers 299 bottles.

    Product
    Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2026·2026-04-22

    glo Skin Beauty Remedy Gel recalled as a subpotent hydrocortisone product

    Remedy Gel, hydrocortisone 1%, distributed by glo Skin Beauty is being recalled because the product is subpotent. The action covers 1,060 bottles.

    Product
    Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2026·2026-04-22

    Skin Rehab calming hydrocortisone balm recalled as a subpotent drug

    Skin Rehab Calming Skin Gel Hydrocortisone Balm, hydrocortisone 1%, is being recalled because the product is subpotent. The action covers 2,895 bottles.

    Product
    Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2026·2026-04-22

    Avantor magnesium chloride active pharmaceutical ingredient recalled as subpotent

    Avantor Performance Materials is recalling one lot of bulk Magnesium Chloride 6-Hydrate active pharmaceutical ingredient because the material is subpotent. 36 bottles are affected.

    Product
    Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0445-2026·2026-04-15

    Teva isotretinoin 30 mg capsules recalled as superpotent and subpotent

    Teva is recalling three lots of Isotretinoin Capsules, USP, 30 mg because the product was found to be superpotent and subpotent. 21,984 packages are affected.

    Product
    ISOTRETINOIN — ISOTRETINOIN (ISOTRETINOIN)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0446-2026·2026-04-15

    Teva isotretinoin 40 mg capsules recalled as superpotent and subpotent

    Teva is recalling three lots of Isotretinoin Capsules, USP, 40 mg because the product was found to be superpotent and subpotent. 8,376 packages are affected.

    Product
    ISOTRETINOIN — ISOTRETINOIN (ISOTRETINOIN)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0126-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc recalls 43,765 bottles of Levothyroxine Sodium 88 mcg tablets nationwide due to potency failures where some tablets are stronger and others weaker than labeled.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0123-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc is recalling Levothyroxine Sodium Tablets 25 mcg nationwide due to potency failures. Some tablets are superpotent while others are subpotent, which could affect medication effectiveness.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0122-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc. is recalling Levothyroxine Sodium 200 mcg tablets nationwide due to potency failures—some tablets are superpotent while others are subpotent. Affected lots expire July 2025; patients should contact their healthcare provider.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0121-2025·2024-12-18

    Levothyroxine Sodium Tablets recalled nationwide for potency failures

    Viatris Inc. is recalling 19,549 bottles of Levothyroxine Sodium 175 mcg tablets nationwide due to potency failures. Some tablets contain excessive active ingredient while others contain insufficient amounts.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2025·2024-12-18

    Levothyroxine sodium tablets recalled for potency failures nationwide

    Viatris Inc is recalling Levothyroxine Sodium Tablets USP 75 mcg due to potency failures affecting approximately 63,077 bottles distributed nationwide in the US and Puerto Rico. Some tablets are superpotent while others are subpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0118-2025·2024-12-18

    Drug Recall: Levothyroxine Sodium Tablets Affected by Potency Failures

    Viatris Inc recalls 92,512 bottles of Levothyroxine Sodium tablets with potency failures—some are stronger than intended, others are weaker than intended.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0120-2025·2024-12-18

    Levothyroxine sodium tablets recalled for potency failures nationwide

    Viatris Inc is recalling Levothyroxine Sodium Tablets USP 150 mcg nationwide due to potency failures. Affected lots containing both subpotent and superpotent tablets expire June 2025.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0127-2025·2024-12-18

    Levothyroxine sodium tablets recalled for potency failures nationwide

    Viatris Inc is recalling Levothyroxine Sodium 100 mcg tablets for potency failures causing some tablets to be too strong and others too weak. Approximately 65,169 units are affected nationwide.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0119-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Due to Potency Failures

    Viatris Inc is recalling Levothyroxine Sodium Tablets USP, 137 mcg due to potency failures in some tablets being stronger or weaker than specified. The recall affects 118,324 bottles distributed nationwide in the United States and Puerto Rico.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2018·2017-11-22

    PharMEDium Recalls Hydromorphone Injection Due to Potency Failure

    PharMEDium Services is recalling 499 syringes of Hydromorphone HCl injection because the product failed potency specifications.

    Product
    Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0214-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Potency Failures

    Virtus Pharmaceuticals is recalling 24,444 bottles of Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in inconsistent drug potency.

    Product
    Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0156-2017·2016-12-07

    Burel Pharmaceuticals Recalls UROLET MB Tablets Due to Manufacturing Deficiencies

    Burel Pharmaceuticals is recalling UROLET MB Urinary Antiseptic tablets because manufacturing deficiencies may cause the product to fail potency or uniformity tests.

    Product
    UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 3557
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1989-2016·2016-06-22

    Excelsior Heparin Lock Flush Syringes Recalled for Potency Failure

    Excelsior Medical Corp is recalling specific lots of Heparin Lock Flush syringes because they failed potency testing.

    Product
    Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0856-2016·2016-05-25

    Allegiant Health Recalls Col-Rite Stool Softeners for Potency Issues

    Allegiant Health is recalling specific lots of Col-Rite stool softeners because they failed potency tests. Consumers should stop using the product and return it to the pharmacy.

    Product
    col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0024-2016·2015-10-21

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

    Ohm Laboratories is recalling specific lots of loratadine tablets because they failed potency testing. Consumers should stop using the affected medication.

    Product
    Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2016·2015-10-21

    Ohm Laboratories Recalls Equaline Loratadine Tablets for Assay Failure

    Ohm Laboratories is recalling Equaline loratadine tablets because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.

    Product
    Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0034-2016·2015-10-21

    Safeway Care Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Safeway Care Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
    Category
    Drug
    Distribution
    Distributed nationwide