The Recall Desk

Hazard

Superpotency recalls

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

What the numbers show

Total
37
Critical
1
Severe
12
Most recent
2025-09-24

Of the 37 superpotency recalls we have scored against our rubric, 1 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (32%) 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 superpotency 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.

26–37 of 37

  • ModerateFDA (Drugs)·D-0499-2019·2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotency

    Advanced Pharma Inc. is recalling Oxytocin 30 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0495-2019·2019-02-20

    Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

    Tris Pharma is recalling 35,280 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0684-2018·2018-04-25

    Lupin Recalls Cefdinir Powder for Oral Suspension Due to Superpotency

    Lupin Pharmaceuticals is voluntarily recalling 40,824 bottles of Cefdinir powder for oral suspension because the drug was found to be superpotent.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0127-2018·2017-12-27

    Claris Recalls Ciprofloxacin Injection Due to Superpotency

    Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection because the product is superpotent. The recall is voluntary and nationwide.

    Product
    Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0124-2018·2017-12-27

    Renaissance Lakewood Recalls Superpotent Fluconazole Injection Bags Nationwide

    Renaissance Lakewood, LLC is voluntarily recalling 24,569 bags of Fluconazole Injection, USP, 2 mg/mL, due to superpotency. The FDA classified this as Class III.

    Product
    Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0859-2017·2017-05-31

    Qualitest Recalls Hydrocortisone Lotion for Excessive Potency

    Qualitest Pharmaceuticals is recalling 109,620 bottles of Hydrocortisone Lotion, USP, 2.5% because the product is superpotent, meaning it contains more active ingredient than specified.

    Product
    HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0029-2016·2015-10-21

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

    Ohm Laboratories is recalling HEB Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.

    Product
    HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0037-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling Children's Q-PAP Acetaminophen Oral Suspension because the product failed an assay test at the 12-month timepoint.

    Product
    CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1538-2014·2014-08-20

    Teva Recalls Carbidopa and Levodopa Tablets Due to Potential Superpotency

    Teva Pharmaceuticals USA is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg, due to the potential for superpotent tablets.

    Product
    Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1241-2014·2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling specific lots of Nicorette 2 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