Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Federal Court for the Northern District of Iowa
FOR IMMEDIATE RELEASE — September 15, 2015 — Cedar Rapids, IA — Iowa Select Herbs, LLC (the “Company”) is conducting a consumer recall for inventory sold between January 1, 2015 and August 17, 2015 pursuant to a Consent Decree issued by the federal court for the Northern District of Iowa. The Consent Decree was issued because the Company manufactured and distributed unapproved new drugs, misbranded drugs, misbranded dietary supplements, and dietary supplements not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements, and therefore adulterated. There are no reports to date of side effects or adverse events.
The recalled products are herbal extracts marketed under the Iowa Select Herbs brand in either an alcohol or alcohol free (A/F) solution packaged in various sizes from 1oz to 1 gallon. The following lots are being recalled:
| PRODUCT | QUANTITY** | LOT | EXP. DATE |
|---|---|---|---|
| CHAPARRAL | 2 | 31467 | 5/19 |
| CILANTRO | 2 | 32446 | 4/20 |
| CYPRESS | 1 | 06305L12 and 6030542 | 4/20 and 9/19 |
| RASBEERRY | 1 | 19183 and 30614 | 4/20 and 12/19 |
| SAGE | 1 | 32880 and 32282 | 4/20 and 12/19 |
| WHITE WILLOW | 2 | 32973 | 4/20 |
| ALISMA | 1 | 130601H040 | 2/19 |
| ELDERBERRIES | 3 | 33223 and 19847 | 5/19 and 6/19 |
| FENUGREEK | 39 | 32684 | 11/19 |
| GOLDENSEAL | 3 | 32996 | 9/19 |
| RHODIOLA | 1 | 131101H504 | 12/19 |
| WHITE PEONY EXTRACT | 80 | 111001H209 | 2/20 |
| YOHIMBE | 4 | 20508 and 32533 | 4/18 |
| ST JOHNS WORT | 1 | 19892 | 2/19 |
| PANAX GINSENG | 1 | 8958 | 12/19 |
| PAPAYA LEAF CAPSULES | 36 | unknown | unknown |
| ZIZIPHUS | 2 | 0515GF | 8/19 |
| ACIA BERRY | 10 | 22345 | 5/17 |
| ALFALFA | 1 | 30464 | 2/19 |
| ALOE VERA | 10 | m10752 | 11/16 |
| ARNICA FLOWERS | 10 | 30599 | 2/19 |
| ARTICHOKE LEAF | 10 | 45894 | 5/17 |
| ASHWAGANDA | 12 | 22349 | 5/19 |
| ASTRAGULUS | 1 | 30900 | 5/19 |
| ATRACTYLODES | 10 | 45811 | 5/17 |
| BEET ROOT | 10 | 22351 | 8/19 |
| BLACK COHOSH ROOT | 2 | 19972 | 8/19 |
| BOSWELLIA SERRATA | 2 | 209tc13 | 7/17 |
| BROAD BEANS | 1 | 15882 | 11/18 |
| BUCHU LEAF | 1 | 30338 | 7/17 |
| CASCARA ROOT | 1 | 17233 | 3/17 |
| CATS CLAW | 1 | 31487 | 4/19 |
| CINNAMON BARK | 3 | 29792 | 5/19 |
| CITRUS PEEL | 1 | 55756 | 4/19 |
| CRANBERRY | 1 | 76542 | 3/17 |
| CUDWEED | 1 | 31796 | 3/17 |
| DAMIANA LEAF | 2 | 31265 | 4/17 |
| FENNEL SEED EXTRACT | 1 | 31001 | 4/20 |
| GINGER | 1 | 33500 | 5/19 |
| GINGKO | 1 | 30520 | 8/18 |
| GRAPESEED | 3 | 32574 | 2/19 |
| GREEN TEA | 1 | 32513 | 2/19 |
| HAWTHORNE BERRY | 1 | 96483 | 2/20 |
| LOBELIA LEAF | 1 | 31266 | 6/19 |
| MOMORDICA GALLON | 1 | 58545F | 6/19 |
| Nettle Leaf (4oz) | 4 | 56598 | 5/19 |
| OREGANO | 2 | 19976 | 5/18 |
| Organic Papaya Leaf | 1 | unknown | unknown |
| POMEGRANATE | 1 | 15114217282 | unknown |
| PROPOLIS EXTRACT | 1 | 22386 | 8/18 |
| PSOREALEA SEED | 1 | 49697 | 2/19 |
| REISHI | 1 | 8427 | 2/20 |
| RHUBARB ROOT | 1 | 30176 | 2/18 |
| SANGRE DE GRADO | 1 | 32900 | 2/18 |
| SARSPARILLA | 1 | 30709 | 7/19 |
| SCHIZNDRA | 1 | 22389 | 7/18 |
| TUMERIC | 1 | 37441 | 7/20 |
| VALERIAN ROOT EXTRACT | 24 | 31-Mar | 4/20 |
| YARROW FLOWERS | 24 | 22396 | 7/18 |
| PAPAYA LEAF EXTRACT (Various sizes) | 999 | 33161; R1380ST; 52972 | 4/20 |
| Â BILBERRY | 1 | 19889 | 5/19 |
| ACEROLA BERRY | 10 | 32795 | 4/19 |
| ASTAGULUS ROOT | 13 | 31685 | 5/19 |
| BAYBERRY | 1 | 31186 | 4/20 |
| BILBERRY LEAF | 10 | 19889 | 5/19 |
| BITTER MELON | 1 | 58545F | 5/19 |
| BLACK CURRANT | 1 | 64832 | 5/17 |
| BLOOD ROOT | 1 | 30746 | 5/19 |
| Burdock Root | 24 | 20771 | 4/20 |
| Chamomile Flowers | 10 | 31778 | 3/19 |
| CHICORY Root | 2 | 55426 and 55910 | 4/20 |
| COLD BE GONE (Various Sizes) | 300 | 87366 | 1/20 |
| Dandelion Leaf | 26 | 324966 | 9/20 |
| DANDELION ROOT | 21 | 30902; 32945; 20792; 33154; 33583 | 4/20 and 9/19 |
| DULSE LEAF | 2 | 22356 | 4/20 |
| ECHINACEA PURP. (various sizes) | 6 | 32263 | 4/20 |
| ELEUTHERO ROOT | 1 | 30469 | 12/19 |
| GARCINIA FRUIT | 4 | 21484 | 6/19 |
| GINGER ROOT | 22 | 31123 and 33500 | 5/19 |
| Graviola Leaf | 17 | 22363 | 9/20 |
| GYMNEMA SYLVESTRE | 28 | m10866 | 2/19 |
| HIBISCUS | 2 | 30763 | 3/19 |
| JERUSALEM ARTICHOKE | 24 | 5514 | 5/19 |
| JEWEL WEED | 4 | 17544800916 | 5/19 |
| JUNIPER BERRY | 2 | 19836 | 5/19 |
| KAVA KAVA | 29 | 30540 and 33660 | 2/20 |
| Lemon Balm Leaf | 12 | 32700 | 2/20 |
| LICORICE ROOT | 130 | 32698 and 33380 | 2/20 |
| MAGNOLIA BARK | 2 | PAS130828 | 4/20 and 5/19 |
| Marshmallow Root | 3 | 30933 | 4/19 |
| MILK THISTLE EXTRACT (various sizes) | 113 | 32358; 32964; 631H42200122 | 4/20 and 10/19; 10/19;1019 |
| MUIRA PUAMA | 22 | R11165 | 1/20 |
| NETTLE LEAF | 1 | 20769 | 5/19 |
| OATSTRAW | 49 | 31953 and 33183 | 9/19 |
| OATSTRAW EXTRACT | 60 | 31953 and 33183 | 9/19 |
| OLIVE LEAF EXTRACT | 42 | 32772 | 5/19 |
| Osha Root | 35 | 32303 | 3/20 |
| Propolis Resin | 1 | 22386 | 8/18 |
| Pygeum Bark | 39 | 32407 | 12/19 |
| QUACK GRASS | 2 | 20668 | 12/19 |
| Saw Palmetto Berry | 20 | 32654 | 9/19 |
| Scullcap | 3 | 32863 | 4/19 |
| SOLOMON SEAL | 3 | 350150980313 and 32862 | 2/19 |
| SUMA ROOT | 3 | 210535 | 2/19 |
| WORMSEED | 25 | 0415AN01 | 7/20 |
| YUCCA ROOT | 2 | 31990 | 2/19 |
**Quantity refers to the number of units distributed and not the size of the unit (e.g. ounces or gallons).
The recalled products were sold nationwide between January 1, 2015 to August 17, 2015 to wholesalers and consumers using the Company’s website and through online marketplace websites, such as Amazon and Ebay.
Iowa Select Herbs is notifying its wholesale and retail customers through written correspondence. We urge consumers who have purchased these products to immediately discontinue their use and contact their physician if they have experienced any problems that may be related to taking these products. The Company is advising consumers to return the products to their place of purchase. Consumers may also return products directly to Iowa Select Herbs. Customers can call the Company at 319-826-1000 Monday through Friday from 9:00 am – 5:00 pm CST for instructions on the return and refund process.
Any adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
- Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf. Mail to address on the preaddressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.