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Lower risk Food recall · FDA · Published December 31, 2014

Thera Beta Carotene Recall: Missing Labeling Info

The Harvard Drug Group recalls Thera Tablets with Beta Carotene (Lot M-00953) due to missing labeling information on blister packets.

🇺🇸 FDA recall #F-0925-2015FoodThera ›
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Recalling firmThe Harvard Drug Group, LLC31778 Enterprise Dr · Livonia, MI 48150-1960
✎ GovInfoNow plain-language explainer

The Harvard Drug Group, LLC is recalling specific lots of Thera Tablets with Beta Carotene because the blister packets are missing required labeling information. This issue was identified after a complaint received on December 16, 2014, revealed that some 2 x 5 blister cards inside cartons lacked product details on the back. The recall affects approximately 5,700 unit doses distributed across several U.S. states. Read more at govinfonow.com/recall/28296-harvard-drug-group-thera-tablets-beta-carotene-missing-labeling-on.

Source Summary by GovInfoNow · govinfonow.com/recall/28296-harvard-drug-group-thera-tablets-beta-carotene-missing-labeling-on · Updated October 12, 2026 · FDA enforcement record: FDA #F-0925-2015

Cite this page

“Thera Beta Carotene Recall: Missing Labeling Info.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/28296-harvard-drug-group-thera-tablets-beta-carotene-missing-labeling-on. Based on FDA recall #F-0925-2015 (https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-0925-2015%22&limit=1).

The Food and Drug Administration announced on Dec. 31, 2014, that The Harvard Drug Group, LLC is recalling Thera Tablets with Beta Carotene because blister packets were missing required labeling information. This voluntary Class III recall affects 5,700 unit doses distributed domestically.

How to tell if you have it

  • Brand: Thera
  • Product: Thera Tablets with Beta Carotene Dietary Supplement
  • Lot Number: M-00953
  • Expiration Date: 06-2015
  • UPC Code: 3 09040 53961 8

The hazard

The firm investigated a complaint received on Dec. 16, 2014, and found that six 2 x 5 blister cards inside a carton were missing some or all of the product information on the back of the blister card.

Context

GovInfoNow's records show The Harvard Drug Group, LLC has had other recalls since June 10, 2015, including methylergonovine tablets recalled on June 16, 2026, due to subpotent drug risk. Other recent recalls of similar products include Zarlengo Gelato (March 26, 2026), Pain Away Herbal Supplement (Nov. 20, 2025) and Sinus Cap Herbal Supplement (Nov. 20, 2025).

How to tell if you have this one

Check your bottle for Lot Number M-00953 and an expiration date of 06-2015. Verify the UPC Code is 3 09040 53961 8. Inspect the individual blister cards to see if any product information is missing from the back of the packaging.

  • Brand
    Thera
  • Product
    Thera Tablets with Beta Carotene Dietary Supplement
  • Category
    Food

Where it went and when

Where it was distributed

Distributed in 27 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “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:” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Dec 31, 201412. FDA classified it Class III: Jan 23, 201523. Published in FDA’s Enforcement Report: Feb 4, 201534. FDA terminated the recall: Mar 9, 2016420142016
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #F-0925-2015 (December 31, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for F-0925-2015 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA