FDA Issues Warning Letter to Seafood Processor for Failures in HACCP

This FDA Warning Letter, issued to a seafood firm, demonstrates examples of how monitoring was not done correctly for handling pasteurized seafood.

From the report, the company "did not have monitoring records for the receiving and storage of pasteurized canned crab meat. Example, "pasteurized canned crab meat that was received by [the] firm in December of 2025, was stored in [the] cooler without ice while other cans were stored with ice, but not with a sufficient amount of ice to completely surround each can. Furthermore, the thermometer located inside the cooler measured the ambient air temperature to be approximately (b)(4)°F at the beginning of the inspection and after three hours approximately (b)(4)°F.

The reason...."Pasteurized canned crab meat is thermally processed to control non-proteolytic C. botulinum and should be held at 40°F to control proteolytic C. botulinum. When temperatures are between 50°F and 70°F, the maximum cumulative exposure time limit to control proteolytic C. botulinum is 11 hours. After 11 hours, the product is considered to be unsafe due to potential formation of botulinum toxin, the deadliest known toxin."

The FDA response goes on further regarding procedures for monitoring.   "Because [the procedures] indicated that you received pasteurized crab meat refrigerated or with ice, your HACCP plan should cover each manner that the product is received. When pasteurized crab meat is received refrigerated without ice the critical limit should list that the product is held at an ambient temperature 40°F or below with continuous temperature monitoring throughout transit for each shipment. When product is received on ice, the critical limit should list product is to be completely surrounded by ice at the time of delivery with monitoring the amount of ice in a designated number of containers from each shipment selected to be representative. Additionally, as a verification procedure you should periodically measure the internal temperature of the product to ensure that the ice is sufficient to maintain 40°F or below."

The FDA Letter goes on to discuss failures in corrective actions, monitoring of sanitation, and training.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/city-market-inc-727003-05152026
WARNING LETTER
City Market, Inc.
MARCS-CMS 727003 — May 15, 2026

FDA Issues Warning Letter to NJ Bakery for Non-compliance to FDA Regulations

FDA issued a Warning Letter to Aversa's Italian Bakery, Turnersville, NJ.   The issue was that they were not in compliance with FDA regulations, although the estimated size of the business, would mean that they should have a Food Safety Plan.  But not only did the company not have a Food Safety Plan, but they were not compliant with allergen labeling regulations, did not have allergen controls in place, and had not registered as required for food operations.   It was as if they were operating as a small retail operation, but the scope of the operation had far exceeded that level.

You wonder why some State inspector didn't provide better guidance?  You see this from time to time...a small retail operation that steadily grows over time, never considering the fact they have achieved sufficient size/scope that they are under FDA's radar.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aversas-italian-bakery-722904-05202026
WARNING LETTER
Aversa's Italian Bakery
MARCS-CMS 722904 — May 20, 2026

Puerto Rican Firm Recalls Pancake Mix for Incorrect Phrasing Regarding Allergen Labeling

Ballester Hermanos, San Juan, Puerto Rico, is recalling a limited number of 5.99OZ (170GR) pouches of PEARL MILLING COMPANY ORIGINAL PANCAKE & WAFFLES (MEZCLA PARA PANQUEQUES Y WAFFLES) COMPLETE due to undeclared milk and soy.   The recall was initiated after it was discovered that the label stated "may contain milk and soy" instead of "contains milk and soy." Consequently, the objective of this recall is to notify consumers of the incorrect labeling information.

Comment:  The rules are the rules when it comes to allergen labeling.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ballester-hermanos-issues-recall-due-undeclared-soy-and-milk-pearl-milling-company-original-pancake
Ballester Hermanos Issues a Recall Due to Undeclared Soy and Milk in Pearl Milling Company Original Pancake & Waffles (MEZCLA PARA PANQUEQUES Y WAFFLES) Complete 5.99oz (170gr) Distributed in Puerto Rico
Summary
Company Announcement Date:  June 04, 2026
FDA Publish Date:  June 05, 2026
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy and Milk
Company Name:  Ballester Hermanos
 Brand Name: Pearl Milling Company
Product Description:  Pearl Milling Company Original Pancake & Waffles Complete – 5.99 oz (170g)

NY Firm Recalls imported Uneviscerated Dried Fish Due to Risk of Botulism

Prime Food Processing LLC is voluntarily recalling 69 cases of “Dried Herring Fish” because the product was not adequately eviscerated. The sale of uneviscerated fish is prohibited under New York State Agriculture and Markets regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish.  The issue was identified during routine testing conducted by the New York Department of Agriculture and Markets. The recall was initiated after the product was selected and sent for regulatory testing. A subsequent investigation determined that the problem originated from an imported product manufactured in Vietnam. At this time, no illnesses or adverse reactions associated with the affected product have been reported.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/prime-food-processing-llc-issues-safety-warning-regarding-uneviscerated-dried-herring-fish
Prime Food Processing LLC Issues Safety Warning Regarding Uneviscerated “Dried Herring Fish”.
Summary
Company Announcement Date:  June 02, 2026
FDA Publish Date:  June 04, 2026
Product Type:  Food & Beverages
Reason for Announcement:  Product was not adequately eviscerated and may harbor C.botulinum spores
Company Name:  Prime Food Processing LLC
Brand Name:  No Brand
Product Description:  Dried Herring Fish packaged in clear, plastic 7 oz bag with blue trim

Gas Relief Capsules Recalled for Potential Propylene Glycol Contamination Due to Machine Leak

Haleon  is voluntarily recalling four lots of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct. distributed on or about April 13, 2026 to the consumer level. The lots are being recalled due to potential contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.  There is a potential that ingestion of the Softgels contaminated with the diluted propylene glycol-based coolant may result in adverse events such as nausea, vomiting, abdominal pain and diarrhea.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/haleon-issues-voluntary-nationwide-recall-gas-x-extra-strength-softgels-125mg-120-ct-and-72-ct
Haleon Issues Voluntary Nationwide Recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct..
Summary
Company Announcement Date: June 04, 2026
FDA Publish Date: June 04, 2026
Product Type: Drugs
Reason for Announcement: Potential chemical contamination
Company Name: Haleon
Brand Name: Gas-X
Product Description:
Gass-X Extra Strength Softgels 120 and 72ct
Company Announcement
WARREN, N.J., June 4, 2026 — Haleon (NYSE: HLN) is voluntarily recalling four lots of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct. distributed on or about April 13, 2026 to the consumer level. The lots are being recalled due to potential contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Listeria Outbreak, 8 Cases and One Death, Linked to Requeson Style Cheese; MD Dairy Recalls Product

The FDA and CDC, are investigating a multi-state, multi-year outbreak of Listeria monocytogenes infections potentially linked to requeson, a soft cheese similar to ricotta.  Based on epidemiological information collected by CDC, a total of 8 people infected with the outbreak strain of Listeria have been reported from 3 states. Sick people's samples were collected on dates ranging from March 6, 2023, to May 9, 2026.

On May 27, 2026, NYS AGM conducted an inspection at the retailer's cheese distributor, which identified Clover Hill Dairy, LLC of Mechanicsville, MD as the requeson cheese manufacturer. A sample collected from an unopened 18-pound sealed bucket of requeson manufactured by Clover Hill Dairy, LLC also tested positive for Listeria monocytogenes; WGS analysis is pending.

On June 3, 2026, Clover Hill Dairy, LLC issued a voluntary recall of its requeson/soft ricotta products. Consumers and retailers should not eat, serve, or sell recalled requeson cheese.

("Requesón cheese is a type of fresh cheese that originated in Spain and is common in Mexican cuisine as well. It is a soft and crumbly cheese made from whey protein, similar to ricotta cheese. Requesón cheese has a mild and slightly sweet flavor, making it a versatile ingredient in both savory and sweet dishes. (link)")

Case Counts

Total Illnesses: 8

Hospitalizations: 7

Deaths: 1

Last specimen collection date: May 8, 2026

States with Cases: MD, NY, VA

Product Distribution*: MD, NY, VA

*Distribution has been confirmed for states listed, but product could have been distributed further, reaching additional states

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-soft-cheese-june-2026
Outbreak Investigation of Listeria monocytogenes: Soft Cheese (June 2026)
Do not eat, sell, or serve recalled requeson/soft ricotta cheese. FDA’s investigation is ongoing.

CA Establishment Recalls Soup Dumpling Products for Undeclared Peanut in Peanut Oil

Synear Foods USA, LLC, a Chatsworth, Calif. establishment, is recalling approximately 71,603 pounds of frozen not-ready-to-eat (NRTE) pork and crab soup dumpling products due to misbranding and undeclared allergens, specifically peanut,  which is not declared on the product label.  The problem was discovered by FSIS inspection personnel during a routine allergen verification task. FSIS personnel identified that the products were formulated with peanut oil, but peanuts were not declared on the finished product label. The establishment determined that a formulation change led to the mislabeling.

Comment:  Does peanut oil contain peanut allergen?  It depends on the type of peanut oil.  If highly refined, then no.  If artisanal, crude or cold pressed, then yes.  If one is going to use peanut oil, best to understand the labeling requirements of the oil being used.


FSIS Announcement
https://www.fsis.usda.gov/recalls-alerts/synear-foods-usa-llc-recalls-frozen-pork-and-crab-soup-dumpling-products-due
Synear Foods USA, LLC Recalls Frozen Pork and Crab Soup Dumpling Products Due to Misbranding and Undeclared Allergens

WASHINGTON, May 31, 2026 – Synear Foods USA, LLC, a Chatsworth, Calif. establishment, is recalling approximately 71,603 pounds of frozen not-ready-to-eat (NRTE) pork and crab soup dumpling products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains peanut, a known allergen, which is not declared on the product label.

Michigan Firm Recalls Cheese Bread Due to Potential for Salmonella, Another Recall Linked to Suspect Dry Milk Powder Supply Issue

Champion Foods LLC of New Boston, Michigan, is voluntarily recalling certain batches of Motor City Pizza Co. 5 Cheese Bread (“5 Cheese Bread”) because they have the potential to be contaminated with Salmonella. This action follows a California Dairies, Inc. milk powder recall due to a concern of potential Salmonella contamination.   The recalled milk powder was supplied to a third-party manufacturer that provides a seasoning blend used in the 5 cheese sauce blend.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/champion-foods-recalls-some-batches-motor-city-pizza-co-5-cheese-bread-because-possible-health-risk
Champion Foods Recalls Some Batches of Motor City Pizza Co. 5 Cheese Bread Because of Possible Health Risk
Summary
Company Announcement Date:  May 29, 2026
FDA Publish Date:  June 01, 2026
Product Type:  Food & Beverages  
Reason for Announcement:  Possible Salmonella Contamination
Company Name:  Champion Foods LLC
Brand Name:  Motor City Pizza Co.
Product Description:  Motor City Pizza Co. 5 Cheese Bread Single and 2 Packs

FDA Issues Warning Letter to Illinois Sprout Operation

FDA issued a Warning Letter to Shineluck Foods of Chicago IL, a mung bean sprout operation.  There were a number of issues, specifically involving the lack of Listeria testing in the post processing environment and inadequate testing spent sprout irrigation water as required by regulation, as well as other issues.   One interesting note was the retesting of one sample of spent sprout irrigation water (SSIW) where there was a positive E. coli result.

"After you received a positive E. coli O157:H7 finding in an SSIW sample, you stated that you collected another sample from the same bin on August 22, 2025, which tested negative. However, this additional test does not indicate that the SSIW was not contaminated with E. coli O157:H7 because it was conducted using a second sample from the same production batch, rather than on the same enrichment sample that resulted in the presumptive positive from the screening test."

The company could have retested 10 samples and all came out negative, but that does not negate the positive sample they did receive.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shineluck-foods-inc-720155-04292026
WARNING LETTER
Shineluck Foods, Inc.
MARCS-CMS 720155 — April 29, 2026

FDA Issues Warning Letter to Michigan Pet Treat Manufacturer

FDA issued a Warning Letter to Best Buy Bones of Mount Morris, MI for "evidence of significant violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals".  "During the inspection, on September 9, 2025, an FDA investigator collected samples of your Nature's Own Pet Chews Bully Bites, lot 9/2027. Sample analysis revealed that the sampled lot contained Salmonella Uganda."

While the Warning Letter points out items that were bad within the operation, it also points out how the response to the Inspectional Observations as detailed in the 483 report were not adequate for providing proof to FDA that the corrective actions were adequate.  

For example, the company had not established adequate cooking procedures and attempted to correct that issue.  However, FDA stated, "You indicated that the root cause for product not reaching required time and temperature for your preventive control was due to not having established minimum operational cook times and temperatures in your Food Safety Plan, and that you need to account for variance in temperature monitors and temperature ramp times that can alter operating minimums. You indicated that you have now established minimum operational cook times and temperatures for all products in your Food Safety Plan. However, we are unable to evaluate the adequacy of your corrective actions because you have not provided supporting documentation to demonstrate that you are consistently and adequately implementing your corrective actions. For instance, you have not provided a copy of your revised Food Safety Plan and applicable monitoring records."

This is a good document to review in what FDA looks for in the company's response regarding its corrective actions.


https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/best-buy-bones-inc-719212-04302026
WARNING LETTER
Best Buy Bones, Inc.
MARCS-CMS 719212 — April 30, 2026