Recall Radar

ULTRAtab Laboratories recalls Electrolyte tablet and 8 more: label issue

February 16, 2022 · ULTRAtab Laboratories Class II

Class IIFDA’s middle class: use of the product may cause temporary or medically reversible adverse health consequences, or the chance of serious harm is remote.
Reason for the recallcGMP Deviations

Find the official FDA enforcement report

Recall at a glance

Recalling company
ULTRAtab Laboratories
Location
Highland, NY
Reported by FDA
February 16, 2022
Recall started
October 6, 2021
Risk class
Class II
Status (latest data we have)
Terminated
Type
Voluntary: Firm initiated
Category
Supplements and infant formula
Reason type
Labeling and quality

Is my product affected?

Compare your product’s name, size and lot or date codes with the list below. A recall usually covers only specific codes.

  • Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 26,682,419 tablets
    Codes: Product Codes: M693 Bulk Lots: 18J001, 18J002, 18J003, 18L035, 18L036, 18M013, 18M014, 19A044, 19A045, 19B042, 19B043, 19B066, 19C006, 19C007, 19E065, 19E066, 19J045, 19J046
  • MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 42,352,387 tablets
    Codes: Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050
  • Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 1,478,344 tablets
    Codes: Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023
  • Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 5,853,539 tablets
    Codes: Product Codes: M976 Bulk Lots: 19B050, 19F063
  • Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 1,606,966 tablets
    Codes: Product Codes: M961L Bulk Lots: 19E030, 19E031
  • Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 4,250,842 tablets
    Codes: Product Codes: M943 M943L Bulk Lots: 16K038, 18B075
  • Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 1,904,760 tablets
    Codes: Product Codes: M960L Bulk Lots: 19E021, 19E022
  • Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 955,928 tablets
    Codes: Product Codes: M975 Bulk Lots: 19E058
  • Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Quantity: 1,393,353 tablets
    Codes: Product Codes: M962L Bulk Lots: 19E032, 19E033

Where it was distributed

Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.

What to do

If you have this product, check the codes above. FDA recall notices often tell consumers to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information, and if you are unsure, do not eat it. If someone becomes ill after eating a recalled food, contact a healthcare professional. See FDA’s recalls and safety alerts for company announcements.

Frequently asked questions

What was recalled?

ULTRAtab Laboratories recalled 9 products, including Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY.

Why was it recalled?

cGMP Deviations

What does Class II mean?

FDA’s middle class: use of the product may cause temporary or medically reversible adverse health consequences, or the chance of serious harm is remote.

Where was it sold or shipped?

Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.

What should I do if I have this product?

Compare the product name, size and lot or date codes with the details on this page. FDA recall notices often tell you to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information. If you are unsure, do not eat it.

Similar recalls in supplements and infant formula

Sources

Data provided by the U.S. Food and Drug Administration (FDA) through openFDA, shown as published and not validated by this site. This site is independent and is not affiliated with or endorsed by FDA. It covers FDA-regulated foods; meat, poultry and egg products are regulated by USDA. Do not rely on this site for medical decisions: for health concerns contact a healthcare professional, and always follow the official notice and the company’s instructions. Terms and disclaimer.