The Recall Desk

Hazard

Incorrect Formulation recalls

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

What the numbers show

Total
16
Critical
2
Severe
4
Most recent
2026-08-12

Of the 16 incorrect formulation recalls we have scored against our rubric, 2 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (25%) 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 incorrect formulation 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.

1–16 of 16

  • ModerateFDA (Drugs)·D-0740-2026·2026-08-12

    Pediatric TPN Bags Recalled for Incorrect Formulation

    Central Admixture Pharmacy Services is recalling two patient-specific pediatric TPN bags due to incorrect product formulation. The recall affects lots 20-1535990-0-1 and 20-1535892-0-1 with an expiration date of July 16, 2026, distributed in Georgia only.

    Product
    Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0618-2026·2026-07-01

    Pediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation

    Central Admixture Pharmacy Services recalls a patient-specific pediatric TPN (Total Parenteral Nutrition) bag because it did not contain copper and famotidine as labeled.

    Product
    Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0524-2026·2026-05-13

    TPN Bag Recalled for Missing Insulin Formulation Error

    Central Admixture Pharmacy Services is recalling a patient-specific TPN bag because it did not contain insulin as listed on the label. Patients relying on this product for the labeled insulin dosage may face serious health risks.

    Product
    TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0221-2026·2025-12-17

    Compounded ophthalmic syringes recalled over an incorrect product formulation

    Fagron Compounding Services is recalling 2,980 syringes of a compounded topical ophthalmic solution over an incorrect product formulation.

    Product
    Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0231-2022·2021-11-17

    Tadalafil Tablets Recalled Due to Incorrect Product Formulation

    Sun Pharmaceutical is recalling Tadalafil Tablets USP 20 mg due to use of an incorrect grade of Crospovidone during manufacturing. The recall affects 36,786 bottles distributed to one distributor.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0099-2021·2020-11-25

    Grato Holdings Recalls Homeopathic Energy Catalyst for Undeclared API

    Grato Holdings is recalling 399 bottles of Homeopathic Energy Catalyst due to an undeclared active pharmaceutical ingredient and incorrect formulation.

    Product
    Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0518-2019·2019-03-13

    Leiter's Recalls Cefuroxime Intravitreal Injection Due to Incorrect Formulation

    Leiter's Enterprises is recalling 569 vials of Cefuroxime 10 mg/mL intravitreal injection because the drug was compounded with sterile water instead of sterile 0.9% Sodium Chloride.

    Product
    Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0089-2019·2018-10-31

    Westlab Pharmacy Recalls Alprostadil Injectable Vials Due to Incorrect Formulation

    Westlab Pharmacy is recalling 80 vials of Alprostadil 500 mcg/mL Injectable due to an incorrect product formulation. The recall covers nationwide distribution.

    Product
    Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0920-2018·2018-07-25

    Hain Celestial Recalls alba BOTANICA Sunscreen Due to Incorrect Formulation

    The Hain Celestial Group is recalling alba BOTANICA sport mineral sunscreen because the wrong product formulation was placed in the packages.

    Product
    alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0031-2018·2017-11-01

    Lucky Mart Recalls Piyamping Anti-Itch Lotion Due to Incorrect Formulation

    Lucky Mart Inc. is recalling Piyamping Anti-Itch Lotion because it contains dexamethasone instead of the labeled hydrocortisone.

    Product
    PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., LTD., Distributor: Lucky Mart, El Monte, CA 91733, NDC 68085-8012-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1517-2016·2016-04-27

    Stryker GDC 360 Detachable Coils Recalled for Incorrect Device Formulation

    Stryker Neurovascular is recalling 316 GDC 360 Detachable Coils because an incorrect Device Formulation Unit (DFU) was packaged with the product.

    Product
    GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients general medical conditio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1088-2015·2015-06-03

    Strohecker's Pharmacy Recalls Testosterone Cypionate Vials Due to Incorrect Formulation

    Strohecker's Pharmacy is recalling 365 vials of Testosterone Cypionate 200 mg/mL because they contain Estradiol Valerate 20 mg/mL instead.

    Product
    Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx Only, Lot# T-1201S14, Compounded by Strohecker's Pharmacy.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0335-2015·2015-01-14

    Right Value Recalls Glutathione Injectable Due to Incorrect Gas Formulation

    Right Value Drug Stores is recalling specific lots of Glutathione 200 mg/mL Injectable because an incorrect gas was used to remove oxygen from the vials.

    Product
    Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-602-2013·2013-06-26

    Mission Pharmacal Recalls Sodium Sulfacetamide and Sulfur Lotion Due to Incorrect Formulation

    Mission Pharmacal Co is recalling 8,437 bottles of Sodium Sulfacetamide 10% and Sulfur 5% Lotion because the active ingredients were formulated too high.

    Product
    Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
    Category
    Drug
    Distribution
    Distributed nationwide