Was There A Konsyl Recall? (Top voted first)

Has there been a recall on this product?

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There was a sort of recall if you call the konsyl manufacturer they will explain to you that it was an international thing that they stopped production to evaluate the product.. it will not be available back in stores until the end of October

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Re: Nona (# 18)

The 'labeling issues' are with the state of CA regarding lead. Not that Konsyl contains lead but if there is any microscopic relation to lead in the form of the containers, packaging, shipping, the product must have the CA warning on the label, and Konsyl did not. I don't know this, but there is always the slight the possibility that lead proximity was of a bigger issue that anyone would care to admit. In any case, CA holds 40 million of the 330 in the US so whatever packaging is used for here, generally winds up being used for all states. It is too costly to have different packaging for each state so a company will simply abide by the most restrictive and use it in all places. What the individual from Konsyl told me when I first called them in September was 'there was a production problem and we had to pull all product'. Those were her words. She then went on to say that they shopped around for a new facility and settled on one in India. When I asked where it had been made previously, she said 'Europe'. Konsyl claims that the formula will be exactly the same as it previously was, but I suspect it will be costlier.

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I too have been conversing with Konsyl and was informed again this AM, that it will be back on store shelves in Nov. They will email anyone who has asked about purchasing it when it is available on their website. In CA, they were non-compliant with the Prop 65 label warnings. This may or may not have had an effect for the whole of the US, but the settlement agreement was not effective until 2014, although it first became an issue in 2011 so the wheels have turned slowly. Konsyl told me that the new facility will be in India rather than Europe which is where it has been. I would imagine that this facility change took quite a bit of time, as well. Here is a link to the settlement agreement between Konsyl and California:

oag.ca.gov/system/files/prop65/settlements/2012-00163S2907.pdf

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Re: WHGC (# 6)

Called Mfg yesterday and talked to Rep for Konsyl. Said it would be available again after Nov 1017. Labeling issues? Said Walmart would be the first to have it in maybe Target.

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Re: John (# 7)

The interesting part is that it has practically disappeared from the shelves and you can't seem to find any information anywhere as to why on the net. This thread is the only thing I have found anywhere.

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Re: WHGC (# 6)

I cannot have the sugar as most of these products do. I need an explanation as to why no one is getting in a new supply? None of the stores here carry it. You can get it from Amazon-but it is $$$$$. I am wondering if there is a health risk now if I use it again? I think we need to be asking questions publicly to get the right answers.

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Re: WHGC (# 6)

Most Psyllium products have Gluten. Some with sugar and some not. I can take neither. A lot on Konsyl info that people are not pulling up. It has been recalled as far back as Oct 2014. Probably the backlog caused sellers not to advertise it. Konsyl recall was dated Oct 2017. This was the 2nd recall. There was no info even given to my Pharmacist that called the Mfg.

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Hi, CatLady!

I haven't found any information saying that there is a current recall on it. The last one I found listed was due to a labeling problem and occurred in 2011.

However, since this isn't an item that completely falls under command of the FDA, the company isn't actually required to log a recall notice with them or any particular entity. Recalls are actually voluntary and up to their discretion, unless it's due to an issue that has the potential to be very dangerous.

Did you try asking at your local stores to see if it was recalled or if they are just out of stock?

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Re: Knox (# 4)

I see online that CVS 's generic Konsyl is still available in some of their stores.

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Re: John (# 8)

Just saw yesterday on a Konsyl site where this product was recalled in 2014? Sd labeling dispute? Then it was updated to Oct 1017? Keep digging everyone!!! Please post any new info.

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Re: Christine (# 17)

I am not comfortable with the product being mfg in India. Why was there a change? Why not in the US? It is cheaper to produce in another country. Dispute with Calif has nothing to do with why it is moving mfg. Still a lot of questions to me. I have tried Benefiber, Metamucil and 2 others. However I have not had good results with them. Either don't work or I have to use 3 times as much. I have alot of health issues as I have to have this Fiber. Cannot take Wheat Bran as I can't take Gluten.

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Re: Verwon (# 1)

I wrote to the company, asking about Konsyl Original. Their response:

"We expect that Konsyl Original Formula 450g canisters will ship to stores in November. As soon as we have additional information we will be sending an update by email to consumers as to when the Konsyl Original Formula 450g canisters will be available for purchase via our website or by contacting Customer Service (800-356-6795 option 2), for direct shipment to your home.

We do not have an anticipated release date for any of our other products at this time.

We sincerely appreciate your patience and understanding during this time."

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c/o FDA recall list:

PRODUCT -
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.

CODE -
Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)

RECALLING FIRM -
Konsyl Pharmaceuticals, Inc. Easton, MD 21601

REASON FOR RECALL -
Labeling: Label Error on Declared Strength; Active ingredient strength is incorrect.

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I ordered another brand, same stuff, from Amazon for $12.92. Tastes same and A little less gritty. It is only the fiber no additives. Called Nutricost psyllium husk

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Update: CVS customer care told me that they now totally discontinued online distribution of their product that mimics Konsyl Original Formula (called “CVS Health Natural Fiber Supplement”). They refused to answer any other questions about a relation to Konsyl’s quality defect. In fact, I now see that Konsyl had referred to it as “critical quality defect”.

All this suggests that there is a particular psyllium husk supplier (who was the provider for Konsyl, CVS, and probably several other products), whose source has a critical quality defect, probably excessive quantities of a toxic substance. If this is true, then stock of such psyllium products purchased, e.g., through Amazon, and perhaps still available at drugstores, may be unsafe, and consumers may have already been adversely affected.

Konsyl now announced that their Original Formula is “coming soon” with a “New Look!” (Who cares about the look). Apparently, they will now be using a new psyllium husk supplier and it took them six months to reorganize. But the issue is not their future product. The issue is that their *previous* products may be unsafe and still consumed by their customers.

Obviously, all companies which may have something to do with this are concerned about being involved in potential litigation, which is why they refuse to answer questions. But consumers are entitled to know whether or not it is safe to use their older products and whether they should be evaluated for lead poisoning or any other particular substance.

Konsyl should reveal who their previous psyllium husk supplier was and what the critical quality defect was. A person who answered the phone at Konsyl customer service had told me that these questions should be addressed to Ms. Kim Vaccari at kvaccari@konsyl.com cc contact@konsyl.com. This, at least, leaves a record that the question was asked, regardless of the fact that she will probably not reply.

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Found this on the FDA Website:

PRODUCT
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.

CODE
Lot #: A44701 (expiry: 07/16) , A44701C (expiry: 07/16), J34701C-1 (expiry: 07/16)

RECALLING FIRM
Konsyl Pharmaceuticals, Inc. Easton, MD 21601

REASON FOR RECALL
Labeling: Label Error on Declared Strength; Active ingredient strength is incorrect.

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Re: Nichole (# 3)

This answer is totally unacceptable. Our Pharmacist said it would not be available again??? Why not? This was a popular product. I have IBS and it has worked for me. I also have Fibromyalgia and the fact that it has no Gluten was a plus. Need more detail. If anyone knows the real story here -please share. Our Pharmacist called the mfg .

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Called the company customer service yesterday. I was told they expect it to be back on wal-mart shelves again sometime after mid December 2017. Said they were voluntary, improving production and updating machinery and manufacture process. They have none to sell directly to consumers either at this time.

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I emailed Konsyl and received an answer on 11-9-17. They said the original formula would be available in November and would be sold in Walmart Stores. They also said they would email their "customers" when Konsyl was in stores. I will return to this chat when I hear from them and post the new information.

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Re: Philip (# 35)

I agree- Maybe none is safe??? Could be Chemical issue???? Getting a little anxious!!

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