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RECALL RECORD — CLASS IIIRecall closedF-0925-2015/FDA enforcement
The Harvard Drug Group, LLC·Dietary Supplements·Dec 31, 2014

Thera Tablets with Beta Carotene Dietary Supplement

What you need to know

Class III

  • What happened

    The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5…

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. An allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

  • Action required

    Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Recall closed · classified by the FDAAL, AZ, CA, CO +23 moreMore supplements

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Product identification

Source: FDA FOOD

Brand nameThe Harvard Drug Group, LLC
Recalling firmThe Harvard Drug Group, LLCLivonia, MI, United States
UPC / barcodes
3 09040 53961 8
Lot / date codes
  • Lot Number: M-00953 Expiration Date: 06-2015, UPC Code: 3 09040 53961 8
Distribution area
ALAZCACOCTFLGAILKYMAMIMOMSNCNENJNYOHORPATNTXUTVAWAWIWV

Domestic: AL, AZ, CA, CO, CT, FL, GA, IL, KY, MA, MI, MO, MS, NC, NE NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV. Foreign: None Foreign:

United States

Quantity affected5, 700 unit doses 10 x 10 cartons
Recall initiationFDA report date: February 4, 2015
FDA recall numberF-0925-2015

Beyond the headline

The recall, in context

The Harvard Drug Group, LLC initiated this supplements recall on December 31, 2014. The FDA enforcement report states: The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a carton was missing some or all of the product information on the back of the blister card. The FDA report lists distribution as: Domestic: AL, AZ, CA, CO, CT, FL, GA, IL, KY, MA, MI, MO, MS, NC, NE NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV. Foreign: None Foreign:.

The FDA enforcement report describes the reason as: The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a carton was missing some or all of the product information on the back of the blister card.

Thera Tablets with Beta Carotene Dietary Supplement was made or distributed by The Harvard Drug Group, LLC in Livonia, MI, United States. This page reflects FDA report F-0925-2015, dated February 4, 2015.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, an allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

FDA definition

The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the UPC and lot code against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Undeclared allergen

Symptoms to watch for

Hives, swelling, wheezing, coughing, vomiting, abdominal pain or a drop in blood pressure. Anaphylaxis is a medical emergency.

When symptoms may appear

Allergic reactions often begin within minutes to a few hours of eating the allergen.

Higher-risk groups

Anyone with a diagnosed food allergy, especially children, and people with a history of anaphylaxis or asthma.

What to do now

  1. 1Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy.
  2. 2If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services.
  3. 3Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

For a severe allergic reaction, do not wait for a callback or refund process before seeking emergency care.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Thera Tablets with Beta Carotene Dietary Supplement recall?

The Harvard Drug Group, LLC recalled Thera Tablets with Beta Carotene Dietary Supplement in an FDA Class III enforcement action reported as F-0925-2015. The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5…

What should I do if I bought this product?

Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy. If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services. Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

Is the The Harvard Drug Group, LLC recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record F-0925-2015. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.