Mahayograj Guggulu; 120 Vegetarian Capsules, 1/2 lb. bags of powder Dietary Supplement…
Garry N Sun USA Inc. recalled this product and the FDA reported the enforcement action on 9 June 2021 as Class I. The recall was initiated by the firm. State of Iowa collected consumer sample and found high levels of lead - 12,200 mg/kg
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Mahayograj Guggulu; 120 Vegetarian Capsules, 1/2 lb. bags of powder Dietary Supplement, 1030 Matley Lane, Unit A Reno, NV 89502 Serving size: 2 capsule Servings per container: 60 Proprietary Blend - 500 mg Certified Organic Distributed by Garry N Sun USA
- Reason for recall
- State of Iowa collected consumer sample and found high levels of lead - 12,200 mg/kg
- Recalling firm
- Garry N Sun USA Inc.
- Firm location
- Reno, Nevada, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0633-2021
- Quantity
- 18 lbs.
- Distribution
- North Carolina, Arkansas, Hawaii, Idaho, New Mexico, Texas, Florida, Arizona, Washington, Michigan, California, Canada, Germany.
- Initiated
- 17 May 2021
- Reported by FDA
- 9 June 2021
- Terminated
- 2 July 2021
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot number #11850, Use by date of 12/31/2023
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 7 weeks, from 17 May 2021 to termination on 2 July 2021. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 3 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
What this recall was for
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
All 2021 recalls · All FDA food recall data
21 CFR 117.35(b) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.