The Recall Desk

Hazard

Superpotent Drug 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
5
Severe
20
Most recent
2024-12-18

Of the 37 superpotent drug recalls we have scored against our rubric, 5 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (54%) 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 superpotent drug 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-0039-2016·2015-10-21

    Meijer Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Meijer Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0036-2016·2015-10-21

    Ohm Recalls Up&Up Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Up&Up loratadine tablets because they failed an assay test, potentially making them superpotent.

    Product
    Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0020-2016·2015-10-21

    Rite Aid Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Rite Aid Pharmacy loratadine orally disintegrating tablets because they failed an assay test, resulting in a superpotent drug classification.

    Product
    Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1142-2015·2015-06-24

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

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

    Product
    Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0039-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling Children's Q-PAP Acetaminophen Oral Suspension due to a failure of the product assay at the 12-month timepoint.

    Product
    CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE 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 0603-0843-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0038-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling specific lots of 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, CHERRY 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 0603-0842-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0007-2015·2014-10-15

    Zydus Recalls Atenolol Tablets Due to Superpotent Drug Complaint

    Zydus Pharmaceuticals is recalling 5,400 bottles of Atenolol 25 mg tablets nationwide after a pharmacist reported that several tablets appeared noticeably thicker.

    Product
    ATENOLOL — ATENOLOL (ATENOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66447-001·2013-11-13

    Irinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation

    West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because a calculation error resulted in drug levels higher than labeled.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-098-2013·2012-12-26

    Johnson & Johnson Recalls Clean & Clear Foaming Wash for High Salicylic Acid

    Johnson & Johnson is recalling Clean & Clear Advantage 3-in-1 Foaming Wash because it contains superpotent levels of salicylic acid.

    Product
    Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-058-2013·2012-11-28

    Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Superpotent Risk

    Watson Laboratories is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen tablets because they may be oversized and superpotent.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-057-2013·2012-11-28

    Qualitest Recalls Hydrocodone and Acetaminophen Tablets Due to Oversized Pills

    Vintage Pharmaceuticals is recalling 14,445 bottles of hydrocodone and acetaminophen tablets because confirmed complaints found oversized pills with superpotent drug levels.

    Product
    HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
    Category
    Drug
    Distribution
    Distributed nationwide