FDA Drug Recalls and Warnings: Eye Drops Recall; Clinical Trials Violations

Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting a large recall for AvKARE eye drops and artificial tears products.

This installment also highlights FDA warning letters for three clinical trials violations and a fertility center inspection site violation.

How to Read This Report

This report is prepared using the most recent information posted in the FDA’s Enforcement Reports Database (for recalls), Warning Letters Database (for warning letters), and Drug Imports Alerts Database (for drug importers subject to import bans). Not all new entries to the databases are included in this report. Selected entries are chosen based on the type of product and the potential safety impact of the recall or warning.

Recall announcements and warnings are simplified to improve clarity and accessibility. In some cases, additional sources such as company statements, FDA press releases, and industry publications may provide further details. The primary sources for this report include:

Recalls (Enforcement Reports Database)

The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”

While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.

• Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
• Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
• Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.

Warning Letters (Warning Letters Database)

Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. Warning letters are also issued for clinical trial site or procedure violations. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.

Drug Imports Alerts Database

FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.

Drug Recalls

Acetaminophen Tablets

Company: Aurobindo Pharma USA; distributed by: Amazon.com Services LLC

Manufacturing Location: Not listed

Recall Reason: Deviations from Current Good Manufacturing Practice (cGMP): consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

Scope: 4,608 100-count bottles, 325 mg strength

Drug Purpose: Pain relief

Recall Initiation Date: 5/22/2025

Link: FDA Enforcement Report
This recall is directed at retail suppliers, not consumers. This means retailers are instructed to remove products from sale, but does not specifically instruct consumers to take action regarding products currently in their possession.

AvKARE Artificial Tears, Lubricant Eye Drops, Lubricant Eye Gel

Company: AvKARE (distributor, Pulaski Tennessee); BRS Analytical Services (St. Louis, Missouri; initiating recall)

Manufacturing Location: Not disclosed

Drug Description: Over-the-counter eye drops and artificial tears; see enforcement report or recall notice for specific drug names, ingredients, and national drug code (NDC) numbers.

Scope: 75,000 cases (1.8 million cartons)

Recall Reason: Deviations from Current Good Manufacturing Practice (cGMP); and lack of assurance of sterility.

Recall Initiation Date: April 23, 2025; products were distributed and shipped between May 26, 2023, and April 21, 2025.

Link: FDA Enforcement Report and AvKARE recall notice
This recall is directed at retail suppliers, not consumers. Because of the nature and timing of this recall, consumers may wish to check the enforcement report for the list of affected product lot numbers.

Levothyroxine Sodium Tablets (generic for Synthroid brand)

Company: Macleods Pharmaceuticals Ltd.

Manufacturer location: Valsad, Gujarat, India

Scope: 1,344 bottles (1000-count each) of  USP 112 mcg

Drug Purpose: Treats hypothyroidism

Recall Reason: Presence of a foreign substance: black hair found embedded in tablet.

Recall Initiation Date: 5/29/2025

Link: FDA Enforcement Report
This recall is directed at retail suppliers, not consumers. This means retailers are instructed to remove products from sale, but does not specifically instruct consumers to take action regarding products currently in their possession.

Warning Letters for Clinical Trials Site Inspections

FDA’s Bioresearch Monitoring (BIMO) program is responsible for conducting clinical trial site inspections, research data audits, and remote regulatory assessments of FDA-regulated research. The site inspections also help ensure that the rights, safety, and welfare of human subjects participating in clinical trials have been protected.

In recent years, due to staffing shortages, BIMO is conducting far fewer inspections and audits of clinical research. FDA inspectors and auditors warn that this is leading to less informed drug approvals.

Here are summaries of some recent clinical trials sites inspection warning letters.

Warning Letter Date: April 28, 2025

Warning Letter Reference Number: 25-HFD-45-04-01

Clinical Investigator: Nana Barseghian, M.D.

Clinical Trials Location: Northridge, CA

FDA Department issuing Warning: Center for Drug Evaluation and Research (CDER)

FDA Warning: This site failed to ensure that the investigation was conducted according to the clinical trial investigational plan.

The protocol required excluding participants with any risk factors for progression to severe disease, such as obesity, defined as a body mass index (BMI) ≥ 30 kg/m2. Two subjects were allowed to participate and were given the investigational drugs even though they did not meet the eligibility requirements for the study: a 19-year-old female with a BMI of 46.6 kg/ and a 64 year female with a BMI of 36.7.

Although the clinical trial investigator responded that they have clarified the protocol with their CRO (contract research organization), the FDA says the response does not provide sufficient details about how it will ensure adequate oversight of study procedures. Without these details, the FDA is unable to determine whether the corrective action plan is adequate to prevent similar violations in the future. The clinical investigator is ultimately responsible for ensuring that these studies are conducted in accordance with the investigational plan and in compliance with FDA regulations.

Essential Extras: Although not identified in the warning letter, Amicis Research Center is most likely the contract research organization (CRO) associated with the research and site inspection. The original FDA document was titled “Nana Barseghian, M.D./Amicis Research Center” based on the warning letter reference number 25-HFD-45-04-01 as indexed on other websites.

Type of Investigational Drug: The type and name of the investigational drug was not identified or described.

Link: FDA Warning Letter
Read the warning letter for more details about the violations.

Warning Letter Date: March 25, 2025

Warning Letter Reference Number: 25-HFD-45-01-01

Clinical Investigator: Americo F. Padilla, M.D.

Organization: Miami Dade Medical Research Institute/ New Med Research Inc.

Clinical Trials Location: Hollywood, FL

FDA Issuing Office: Center for Drug Evaluation and Research

FDA Warning: The investigator did not obtain permission from two of the research participants’ parents or guardians before enrolling them in the study. For this clinical trial involving children or adolescents, permission from a parent or guardian is required. Permission was only obtained from a sibling in one case and an uncle in the other case. The FDA’s Bioresearch Monitoring Program is unable to determine whether the company’s corrective actions appear adequate to help prevent similar violations in the future. The FDA found systemic failures in the conduct of this clinical investigation.

Type of Investigational Drug: Type of drug being studied is not named in the warning letter, but based on the research descriptions of New Med Research and the research interests of Dr. Padilla, most likely the investigational drug was an ADHD treatment.

Link: FDA Warning Letter
Read the warning letter for more detail about the violations.

Warning Letter Date: February 25, 2025

Warning Letter Reference Number: CBER 25-694273

Recipient: Martin D. Bastuba, M.D., Fertility Centers of California

Organization: Sperm Bank, Inc., doing business as Fertility Centers of California

Clinical Trials Location: San Diego, CA

FDA Issuing Office: Center for Biologics Evaluation and Research

FDA Warning: Inspection of the fertility center found some violations of requirements for FDA-certified donor screening and tests for communicable diseases. For example, some repeat anonymous semen donors were not tested for West Nile Virus (WNV) using an FDA-licensed nucleic acid test (NAT). The FDA found that the company’s initial response to its inspectional observations were inadequate to address concerns.

Link: FDA Warning Letter
Read the warning letter for more details about the violations.

Warning Letter Date: February 4, 2025

Warning Letter Reference Number: 25-HFD-45-02-01

Clinical Investigator: Jack Oswald, CEO, Isothrive, Inc.

Clinical Trials Location: Healdsburg, CA

FDA Issuing Office: Center for Drug Evaluation and Research

FDA Warning: This site was conducting a clinical trial of a “drug” without first filing an investigational new drug application (IND). Isothrive argued the treatment (a dietary supplement) was a GRAS (generally recognized as safe) product and therefore a drug application was not required. However, the FDA says that since the company intends to market the product as a drug, not as a dietary supplement, it needs to file an IND prior to conducting a clinical trial.

Type of Investigational Drug: The specific product and condition being studied is not mentioned in the warning letter, but the company is a  “microbiome therapeutics” company, developing specialized prebiotics and probiotics that treat certain conditions, including GERD (gastrointestinal reflux disease).

Essential Extras: IsoVive is a prebiotic supplement marketed to relieve heartburn. It’s available as a dietary supplement both on the IsoVive website and on Amazon. However, it’s unclear whether the version sold to consumers is the same formulation currently being studied as a drug by its parent company, IsoThrive.

Link: FDA Warning Letter and Isothrive website
Read the warning letter for more details about the violations.