The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-1126-2013·Announced 2013-03-27

Pascalite Capsules Recalled for Potential Lead Contamination

Pascalite, Incorporated is recalling Pascalite Capsules because they may contain violative levels of lead. The product is distributed in the U.S., Canada, UK, Hong Kong, and Australia.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves lead contamination, which is a significant health hazard. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or high-risk contaminants, are rated as Severe.

Plain-English summary

Pascalite, Incorporated is recalling Pascalite Capsules, a dietary supplement for adults and children over 12 years, because the products may contain violative levels of lead. The recalled product consists of 100-count white plastic bottles with screw tops, where each capsule contains approximately 1/4 teaspoon of pascalite powder.

The recall affects a portion of 2,655 units distributed nationally in the United States, as well as in Canada, the United Kingdom, Hong Kong, and Australia. Affected lot numbers are imprinted or handwritten on the bottom of the product and include 2010M, and D10 through 12 with a noted OT, U, V, or W.

Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions. The recall is being conducted to address the potential presence of lead in the pascalite powder.

The recalled product

Product
Pascalite Capsules 100 count white plastic bottle with a screw on top, Pascalite Inc, PO Box 104 Worland, WY 82401 307-347-3872, Dietary Supplement for adults and children over 12 years two capsules daily, each vegi cap (size 00) contains approx. 1/4 tsp pascalite powder.
Manufacturer
Pascalite, Incorporated
Category
Food — Dietary Supplement
Hazard
Affected units
2,655

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot numbers imprinted or hand written include: 2010M
  • and D10 through 12 with a noted OT
  • U
  • V
  • or W. The code information is found on the bottom of the product.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Pascalite, Incorporated under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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