Patanjali Ayurved Limited

65 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNAPPROVED38 refused lines

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

• LIST INGRE12 refused lines

  Ingredients not listed

  The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

• LACKS N/C8 refused lines

  Net quantity statement missing

  The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.

• NO ENGLISH8 refused lines

  Required label information not in English

  Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

• NUTRIT LBL8 refused lines

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

• NEEDS FCE5 refused lines

  Processor not registered for canned or acidified foods

  The manufacturer appeared not to be registered with FDA as a low-acid canned food or acidified food processor, as 21 CFR 108.25 and 108.35 require.

• UNSAFE ADD5 refused lines

  Food additive unsafe under section 409

  The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.

• NO PROCESS4 refused lines

  No scheduled process filed

  The manufacturer appeared not to have filed a scheduled process with FDA, which 21 CFR Part 108 requires for low-acid canned and acidified foods, so the product is treated as made under insanitary conditions.

Questions about Patanjali Ayurved Limited

Is Patanjali Ayurved Limited on an FDA import alert?

Yes. As of October 26, 2026, Patanjali Ayurved Limited is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for giloy-amla juice; amla-aloevera juice with wheat grass; patanjali amla murabba; FDA published the listing on February 6, 2024.

Has FDA refused shipments from Patanjali Ayurved Limited?

Yes. FDA refused 60 shipment lines from Patanjali Ayurved Limited between November 21, 2016 and August 14, 2026. The most recent, on August 14, 2026, was ashwagandha (herbal & botanicals, not teas), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Patanjali Ayurved Limited's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 38 lines) and LIST INGRE (ingredients not listed, 12 lines).

When was Patanjali Ayurved Limited last inspected by FDA?

FDA's most recent inspection of Patanjali Ayurved Limited with a final classification is dated June 30, 2023 and was classified VAI (Voluntary Action Indicated).

What is Patanjali Ayurved Limited's FEI number?

Patanjali Ayurved Limited's FDA Establishment Identifier (FEI) is 3007993199.

Can shipments from Patanjali Ayurved Limited still enter the U.S.?

Shipments of giloy-amla juice; amla-aloevera juice with wheat grass; patanjali amla murabba from Patanjali Ayurved Limited can be detained without physical examination under Import Alert 99-39; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).