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.

1–25 of 37

  • HighFDA (Drugs)·D-0645-2025·2025-09-24

    Aripiprazole 10 mg tablets recalled after testing superpotent in one lot

    Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles are affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0385-2025·2025-04-30

    HYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency

    OurPharma LLC is recalling HYDROmorphone Hydrochloride 50 mg/50 mL cassettes nationwide because the assay results showed higher potency than specification.

    Product
    HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content

    Mylan Institutional is recalling Levothyroxine Sodium tablets nationwide due to subpotent and superpotent units. Patients taking affected tablets may receive incorrect doses of this thyroid medication.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0134-2025·2024-12-18

    Levothyroxine Sodium Tablets Recalled Nationwide for Potency Variance

    Mylan Institutional recalls 1,133 cartons of Levothyroxine Sodium Tablets (137 mcg) nationwide. Three lots contain subpotent and superpotent tablets.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0048-2025·2024-11-27

    Triamcinolone Acetonide Cream USP Recalled for Out-of-Specification Potency Variance

    Padagis is recalling 10,872 jars of Triamcinolone Acetonide Cream USP 0.025% nationwide because some jars contain subpotent or superpotent active ingredient levels. The defect was discovered during long-term stability testing.

    Product
    Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0637-2024·2024-08-28

    Testosterone Gel Recalled by Teva for Excessive Potency

    Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0442-2024·2024-04-24

    Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling

    Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2024·2024-01-24

    FDA Recalls Vasostrict Injection for Exceeding Potency Specifications

    Par Sterile Products recalled Vasostrict (vasopressin) injection because stability testing showed the drug exceeded its upper potency specification limit. The recall involves 1,721 cartons distributed nationwide.

    Product
    VASOSTRICT — VASOSTRICT (VASOPRESSIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1178-2023·2023-10-04

    Prescription Drug Recall: Eligard Leuprolide Contains Higher Than Expected Levels

    Tolmar, Inc. is recalling Eligard (leuprolide acetate) 7.5 mg monthly injectable suspension nationwide because the constituted product contains higher than expected levels of the active ingredient. The affected lot is 13635A1 with expiration date July 31, 2024.

    Product
    ELIGARD — ELIGARD (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0562-2023·2023-05-10

    Seatex Alcohol Antiseptic 80% Hand Sanitizer Recalled for Superpotency and Impurities

    Seatex Alcohol Antiseptic 80% (1-gallon containers) is being recalled because the formula does not meet specifications, with superpotency and impurities present. The recall affects lot 220888 distributed in Florida, Georgia, and Texas.

    Product
    Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-1546-2022·2022-10-05

    Antidepressant Medication Recalled for Excessive Active Ingredient Potency

    Leading Pharma, LLC is recalling Clomipramine Hydrochloride Capsules (25mg) with Lot B14221 due to testing that found 110.6% of the labeled active ingredient strength. The medication was distributed nationwide.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1289-2022·2022-08-03

    Prescription testosterone gel recalled due to out-of-specification potency

    Teva Pharmaceuticals is recalling testosterone gel lot 1403180 after stability testing revealed out-of-specification assay results indicating superpotency. The affected 12,354 cartons were distributed nationwide.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2022·2022-02-02

    Pioglitazone Tablets Recalled for Superpotent and Failed Specifications

    Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.

    Product
    PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0295-2022·2022-01-05

    Lidocaine Hydrochloride Topical Solution recalled for being superpotent

    Teligent Pharma has recalled 6,816 bottles of Lidocaine Hydrochloride Topical Solution 4% nationwide due to the drug being superpotent. The recall is voluntary and involves Lot #16345 with expiration date 01/2024.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0296-2022·2022-01-05

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to superpotency. The affected lot was distributed nationwide.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0280-2022·2021-12-22

    Lidocaine Topical Solution Recalled for Superpotency

    Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% nationwide due to the drug being superpotent. Affected lots are 13262 (Exp. 03/2022) and 14217 (Exp. 08/2022).

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0279-2022·2021-12-22

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0281-2022·2021-12-22

    Lidocaine Hydrochloride Topical Solution recalled for CGMP deviations

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. Affected lots were made at a facility where cracked seals in caps were found on related products.

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0800-2021·2021-09-22

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution, USP 4% due to the product being superpotent. The recall affects 32,544 bottles distributed nationwide in the United States and Canada.

    Product
    Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2021·2021-06-16

    READYPREP CHG Chlorhexidine Gluconate Cloth recalled for superpotency

    Medline Industries is recalling READYPREP CHG 2% Chlorhexidine Gluconate Cloth because the product contains higher-than-specified levels of the active ingredient.

    Product
    READYPREP CHG — READYPREP CHG (CHLORHEXIDINE GLUCONATE 2%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1505-2020·2020-08-26

    Ferring Recalls Desmopressin Acetate Nasal Spray Due to Superpotency

    Ferring Pharmaceuticals is recalling 184,325 vials of Desmopressin Acetate Nasal Spray because the drug is superpotent. The recall is voluntary and nationwide.

    Product
    Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1517-2019·2019-07-31

    Tris Pharma Recalls Hydrocodone and Chlorpheniramine Suspension Due to Potency Issues

    Tris Pharma is recalling 2,550 bottles of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension due to high out-of-specification results for active ingredients and preservatives.

    Product
    HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX — HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2019·2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotency

    Advanced Pharma Inc. is recalling 672 bags of Oxytocin 20 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.
    Category
    Drug
    Distribution
    Distributed nationwide