Has FDA refused shipments from Hamdard Laboratories (India)?

Yes. FDA refused 8 shipment lines from Hamdard Laboratories (India) between December 6, 2017 and February 25, 2026. The most recent, on February 25, 2026, was syrups and molasses, n.e.c., charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Hamdard Laboratories (India)'s shipments?

The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 5 lines) and COLOR LBLG (artificial coloring not declared, 2 lines).

When was Hamdard Laboratories (India) last inspected by FDA?

FDA's most recent inspection of Hamdard Laboratories (India) with a final classification is dated July 17, 2015 and was classified NAI (No Action Indicated).

What is Hamdard Laboratories (India)'s FEI number?

Hamdard Laboratories (India)'s FDA Establishment Identifier (FEI) is 3010199505.

Can shipments from Hamdard Laboratories (India) still enter the U.S.?

Shipments of sharbat rooh afza from Hamdard Laboratories (India) can be detained without physical examination under Import Alert 45-02; 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).

Hamdard Laboratories (India)

FDA import alert and refusal historyImt Manesar, IndiaFEI 3010199505

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As of October 27, 2026, Hamdard Laboratories (India) (Imt Manesar, India) is on the red list of FDA Import Alert 45-02 (Foods with illegal or undeclared colors) for sharbat rooh afza, published by FDA on December 1, 2015, and has 8 FDA import refusals recorded since October 2016.

Data from FDA public records, last checked October 27, 2026. Request a correction

Current status

Import alerts: IA 45-02 · red list
Last import refusal: Feb 25, 2026Syrups and molasses, n.e.c. · UNSAFE COL
Last warning letter: None found
Last inspection: Jul 17, 2015Classified NAI (No Action Indicated)

Every FDA record for Hamdard Laboratories (India)

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

2026

Feb 25, 2026Import refusal
Refused, Syrups and molasses, n.e.c.UNSAFE COL COLOR LBLGEntry KM6-3667160-4
Source

2025

Aug 12, 2025Import refusal
Refused, Syrups and molasses, n.e.c.UNSAFE COL COLOR LBLGEntry KM6-3656439-5
Source
Jan 21, 2025Import refusal
Refused, Syrups and molasses, n.e.c.UNSAFE COLEntry KM6-3638393-7
Source

2021

May 17, 2021Import refusal
Refused, Beverage base not mentioned elsewhere, n.e.c.UNSAFE COLEntry 9PM-2655645-8
Source

2018

Sep 7, 2018Import refusal
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIRECTIONSUNAPPROVEDEntry 9PM-2633993-9Show 2 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIRECTIONS UNAPPROVEDEntry 9PM-2633993-9Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIRECTIONS UNAPPROVEDEntry 9PM-2633993-9Source
Source
Apr 6, 2018Import refusal
Refused, Citrus and other fruits, mixed, toppings and syrupsFILTHYEntry EVJ-0213781-1
Source

2017

Dec 6, 2017Import refusal
Refused, Beverage base, subtropical or tropical fruit, liquidUNSAFE COLEntry EVJ-0198255-5
Source

2015

Dec 1, 2015Import alert listing
Listed on Import Alert 45-02red listSharbat Rooh Afza
Source
Jul 17, 2015Inspection
Inspection classified NAI (No Action Indicated)Foodborne Biological Hazards
Source

Refusal charges, in plain English

UNSAFE COL5 refused lines
Color additive unsafe under section 721
The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.
COLOR LBLG2 refused lines
Artificial coloring not declared
The product appeared to contain an artificial coloring without labeling that states that fact.
DIRECTIONS2 refused lines
DIRECTIONS
UNAPPROVED2 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.
FILTHY1 refused line
Filthy, putrid or decomposed substance
The product appeared to consist in whole or in part of a filthy, putrid, or decomposed substance, or to be otherwise unfit for food.

Questions about Hamdard Laboratories (India)

Is Hamdard Laboratories (India) on an FDA import alert?: Yes. As of October 27, 2026, Hamdard Laboratories (India) is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for sharbat rooh afza; FDA published the listing on December 1, 2015.
Has FDA refused shipments from Hamdard Laboratories (India)?: Yes. FDA refused 8 shipment lines from Hamdard Laboratories (India) between December 6, 2017 and February 25, 2026. The most recent, on February 25, 2026, was syrups and molasses, n.e.c., charged as UNSAFE COL (color additive unsafe under section 721).
Why did FDA refuse Hamdard Laboratories (India)'s shipments?: The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 5 lines) and COLOR LBLG (artificial coloring not declared, 2 lines).
When was Hamdard Laboratories (India) last inspected by FDA?: FDA's most recent inspection of Hamdard Laboratories (India) with a final classification is dated July 17, 2015 and was classified NAI (No Action Indicated).
What is Hamdard Laboratories (India)'s FEI number?: Hamdard Laboratories (India)'s FDA Establishment Identifier (FEI) is 3010199505.
Can shipments from Hamdard Laboratories (India) still enter the U.S.?: Shipments of sharbat rooh afza from Hamdard Laboratories (India) can be detained without physical examination under Import Alert 45-02; 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).

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.