Tag: FDA Recall
What Brands Need to Know Now
By all appearances, the FDA just decided to use one of MoCRA’s sharpest tools—and sooner than expected. On December 18, 2025, the U.S. Food and Drug Administration (FDA) quietly (but significantly) released a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” The document clarifies how the Agency intends to exercise […]
Navigating FDA’s New Scombrotoxin Standards
The FDA recently set sail with a new Compliance Policy Guide (CPG) that brings updated standards to the often-complex world of scombrotoxin (histamine) management in fish and fishery products. This regulatory move impacts a wide range of seafood industry players—from fishermen and processors to distributors and retailers—by setting clear standards on how fish prone to […]
The Wild Waters of an FDA Recall
Recalls are critical for ensuring public safety when products pose health risks but for businesses, this also means reacting quickly to contain the bleeding, limit supply chain disruption and avoid business and reputation damage while simultaneously working alongside the FDA, which plays a pivotal role in managing and helping effectuate recalls – a juggle of […]
Quickly Remove Potentially Violative Product and Minimize Business Disruption and Loss
A pantry staple, granola bars and granola cereals faced a nationwide product recall just before the holidays by the Quaker Oats Company due to potential contamination with Salmonella, a high-risk bacteria that can cause fatal infections in vulnerable populations such as children, the elderly, and those with weakened immune systems. The recall affected Quaker Chewy […]
Protecting Consumers, Limiting Supply Chain Disruption and Avoiding Business and Reputation Damage Quickly and Effectively With product recalls consistently being in the news over undeclared allergens, bacterial contamination, physical hazards, potential of a product’s failure to conform to a performance standard, and many other reasons, consumer’s health and safety are naturally at stake. Companies also […]
Family Dollar Announces Voluntary Recall of OTC Products Stored Outside of Temperature Requirements
Family Dollar initiated a voluntary retail level product recall of FDA regulated products that were stored and shipped to certain stores between May 1, 022 – June 10, 2022 outside of labeled temperature requirements. A complete list of OTC medical devices covered by the recall is provided here , and the earlier July 21, 2022 […]
★★★★★
Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
