Recalls in May 2025

• BRS Analytical Service has issued a voluntary recall of multiple ophthalmic products due to FDA-identified manufacturing concerns.

• The products, distributed by AvKARE, may pose unknown patient risks related to manufacturing deviations.

• Consumers are urged to immediately cease use and return affected items shipped between May 2023 and April 2025.

In an urgent notice to the public, BRS Analytical Service has announced a recall of several eye care products distributed to consumers across the U.S. The recall was triggered after the U.S. Food and Drug Administration identified current Good Manufacturing Practice (cGMP) deviations during a routine audit. 

The FDA said the manufacturing irregularities could lead to products of substandard quality, and although no specific health hazard has been confirmed, potential patient risks cannot be ruled out.

Affected products and distribution timeline

The recall affects a range of over-the-counter eye treatments, including artificial tears, lubricant drops, and carboxymethylcellulose-based gels and solutions. Specifically, the following National Drug Codes (NDC) are involved:

• NDC 50268-043-15: Artificial Tears Ophthalmic Solution

• NDC 50268-066-15: Carboxymethylcellulose Sodium Ophthalmic Gel 1%

• NDC 50268-068-15: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%

• NDC 50268-126-15: Lubricant Eye Drops Solution

• NDC 50268-678-15: Polyvinyl Alcohol Ophthalmic Solution

The affected lots were shipped between May 26, 2023, and April 21, 2025, with expiration dates extending into 2027. Consumers in possession of these products are advised to immediately discontinue use and inspect inventory for matching lot numbers.

What to do

Consumers and retailers are being asked to complete a “Quantity to Return” form and submit it via fax to 931-292-6229 or email to customerservice@avkare.com—even if no affected inventory is currently held. Once this form is submitted, a Return Authorization (RA) will be issued.

Recalled products must be sent to:

R&S Northeast LLC

8407 Austin Tracy Rd

Fountain Run, KY 42133

The return package should be clearly marked “Ophthalmic RECALL”, and a copy of the recall notice must be included. Full credit, including shipping costs, will be issued for returned items.

• Ferrarini USA, Inc. is recalling approximately 70 pounds of ready-to-eat sliced prosciutto di Parma imported from Italy that was not presented for required USDA import reinspection.

• The USDA warns consumers not to eat the prosciutto, as it may still be in home refrigerators or pantries; the product should be discarded or returned to the store of purchase. 

• Questions about the recall can be directed to Ferrarini’s CFO or the USDA Meat and Poultry Hotline, and updates including retail distribution lists will be posted on the FSIS website.

Ferrarini USA is recalling approximately 70 pounds of ready-to-eat sliced prosciutto (cured ham) products that were not presented for import reinspection into the United States. The ready-to-eat sliced prosciutto products were imported on April 21, 2025. The following products are subject to recall:

• 4-oz. vacuum-sealed plastic tray packages containing slices of “FERRARINI PROSCIUTTO DI PARMA PRODUCT OF ITALY” and lot code “2527642” on the backside label of the packaging.

• The products subject to recall bear Italy establishment number “IT 713 L CE” printed inside the Italian mark of inspection located on the front of the package. These items were shipped to retail locations in California.                           

The problem was discovered when a federal establishment notified U.S. Food Safety and Inspection Service that it shipped the sliced prosciutto that was not presented for FSIS import reinspection.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

What to do

FSIS is concerned that some products may be in consumers’ refrigerators and pantries. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact Luca Infantino, chief financial officer, Ferrarini USA, Inc., at 818-256-1622 or luca@ferrariniusa.com.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.