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.

1–25 of 37

  • 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
  • SevereFDA (Drugs)·D-0332-2021·2021-04-21

    Lupin Recalls Cefprozil Oral Suspension Due to Superpotent Drug Concerns

    Lupin Pharmaceuticals is recalling specific lots of Cefprozil for Oral Suspension because the drug may be superpotent. The recall covers bottles distributed nationwide in the USA and Puerto Rico.

    Product
    CEFPROZIL — CEFPROZIL (CEFPROZIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1540-2020·2020-09-02

    Rocky Mountain Sunscreen Lip Balm Recalled for Excess Octisalate

    Yusef Manufacturing is recalling Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm because the active ingredient Octisalate was found at 15% above the label claim.

    Product
    Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1504-2020·2020-08-26

    Ferring Recalls DDAVP Nasal Spray Due to Superpotent Drug Risk

    Ferring Pharmaceuticals is recalling 15,175 bottles of DDAVP Nasal Spray because the drug may be superpotent. The recall is voluntary and nationwide.

    Product
    DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1506-2020·2020-08-26

    Ferring Recalls STIMATE Nasal Spray Due to Superpotent Drug Risk

    Ferring Pharmaceuticals is recalling 29,371 vials of STIMATE nasal spray because the drug is superpotent. The recall is voluntary and nationwide.

    Product
    STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1486-2020·2020-08-12

    Yusef Tropical Lip Moisturizer Recalled for Superpotent Meradimate Ingredient

    Yusef Manufacturing Laboratories is recalling Tropical Lip Moisturizer, SPF 30, because the beginning of the batch is approximately 25% superpotent for the active ingredient Meradimate.

    Product
    Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1300-2020·2020-06-10

    Acella Recalls Superpotent NP Thyroid 15 Thyroid Tablets Nationwide

    Acella Pharmaceuticals is voluntarily recalling 49,128 bottles of NP Thyroid 15 tablets because they are superpotent. The FDA classified this as a Class I recall.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1299-2020·2020-06-10

    Acella Recalls NP Thyroid 15 Tablets Due to Superpotent Drug Risk

    Acella Pharmaceuticals is voluntarily recalling 29,304 bottles of NP Thyroid 15 tablets because the drug is superpotent. The recall covers products distributed nationwide in the US and Puerto Rico.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1298-2020·2020-06-10

    Acella Recalls Superpotent NP Thyroid 15 Tablets Nationwide

    Acella Pharmaceuticals is voluntarily recalling 112,140 bottles of NP Thyroid 15 tablets because the drug is superpotent. The recall covers distribution across the US and Puerto Rico.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1251-2020·2020-04-29

    Yusef Recalls SPF Lip Moisturizers with Excess Oxybenzone

    Yusef Manufacturing is recalling 12,983 tubes of SPF 15 lip moisturizers because they contain up to 150% of the labeled amount of oxybenzone.

    Product
    PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 841
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1860-2019·2019-09-25

    Soothing Sore Relief Lidocaine Cream Recalled for High Potency

    Ridge Properties, LLC is recalling Soothing Sore Relief (lidocaine) Cream, 4%, because the product was found to be contaminated and above specification for lidocaine assay.

    Product
    Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0497-2019·2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotent Drug Concerns

    Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0493-2019·2019-02-20

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of Infants' Ibuprofen because the medication may contain a higher concentration of ibuprofen than labeled.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0494-2019·2019-02-20

    Tris Pharma Recalls Superpotent Infant Ibuprofen Suspension

    Tris Pharma is recalling specific lots of infant ibuprofen suspension because the medication may contain higher concentrations than labeled.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0335-2019·2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of infants' ibuprofen oral suspension because they may contain a higher concentration of the active ingredient.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0337-2019·2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of Infants' Ibuprofen because they may contain a higher concentration of the active ingredient.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0336-2019·2018-12-26

    Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

    Tris Pharma is recalling 19,488 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, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0877-2018·2018-06-20

    Mylan Recalls Maxzide-25 Tablets Due to Slightly High Potency

    Mylan Pharmaceuticals is recalling 1,620 bottles of Maxzide-25 tablets because routine stability testing showed potency slightly above specification.

    Product
    Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0221-2018·2018-01-24

    Pharmedium Recalls Superpotent Phenylephrine Syringes Nationwide

    Pharmedium Services is voluntarily recalling 2,390 syringes of Phenylephrine HCL 100 mcg/mL due to a superpotent drug classification.

    Product
    Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0081-2018·2017-11-22

    Llorens Pharmaceutical Recalls Urin D/S Tablets Due to Potency Issues

    Llorens Pharmaceutical Corp. is recalling Urin D/S Tablets because FDA analysis found the product to be out of specification for assay, resulting in subpotent or superpotent tablets.

    Product
    Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0787-2017·2017-05-24

    Teligent Recalls Desoximetasone Ointment Due to Superpotent Drug Classification

    Teligent, Inc. is voluntarily recalling 3,600 tubes of Desoximetasone Ointment 0.25% in Tennessee due to a superpotent drug classification.

    Product
    Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0126-2017·2016-11-16

    FDA Recalls Wells Pharmacy Testosterone and Anastrozole Pellets

    Wells Pharmacy Network is recalling compounded Testosterone 200 mg/Anastrozole 9 mg Pellets because they are superpotent or subpotent.

    Product
    Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0802-2016·2016-04-13

    Meditech Formula 2 Injection Recalled for Superpotent Drug Ingredient

    Meditech Laboratories is recalling Formula 2 Injection vials because one ingredient exceeded assay specifications, making the drug superpotent.

    Product
    Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0027-2016·2015-10-21

    Good Neighbor Pharmacy Loratadine Tablets Recalled for Potency Issues

    Ohm Laboratories is recalling Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets because they failed potency testing.

    Product
    Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by:
    Category
    Drug
    Distribution
    Distributed nationwide