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& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications FDA Recalls and Warnings: Millions of Eye Drops Recalled Over Leaching Chemical, Cholesterol Drug Mix-Up
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Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions
November 4, 2026
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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 cover recalls involving Artificial Tears Lubricant Eye Drops, atorvastatin, carboxymethylcellulose sodium eye drops, Electric Medicated Balm Ultra Strength, fludrocortisone, olmesartan medoxomil/amlodipine/hydrochlorothiazide, theophylline, and ValuHealth Extra Strength Pain Relief Acetaminophen Caplets. We also examine a recall of 42 compounded drug products from Victory Medical Center Pharmacy, including GLP-1 medications and peptides.
Unless otherwise noted, all recalls are nationwide in the United States.
Consumers may want to check the linked enforcement report for affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall.
How To Read This Report
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.
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. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.
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
Artificial Tears Lubricant Eye Drops
Drug Purpose: Over-the-counter eye lubricant used for temporary relief of burning and irritation from dry eyes and to protect against further irritation.
Company: Preferred Pharmaceuticals, Inc., Anaheim, California
Manufacturing Location: Brooklyn, New York, by Geri-Care
Scope: 480 15 mL bottles
Recall Reason: Lack of assurance of sterility
Recall Initiation Date: October 16, 2026
Essential Extras: The active ingredients are listed as “Glycerin 0.2% Hypromellose 0.2% Polyethylene glycol 400 1%” on this product’s repackaged drug label. Although the FDA enforcement report mentions “Visine” in its product description, these are not Visine-branded eye drops. Instead, the manufacturer’s packaging states that the product’s active ingredients are comparable to those in Visine.
Link: FDA Enforcement Report
Atorvastatin Calcium Tablets (generic for Lipitor)
Drug Purpose: A statin treatment for high cholesterol
Company: MSN Laboratories Private Limited; distributed by Novadoz Pharmaceuticals LLC, Piscataway, New Jersey
Manufacturing Location: Nandigama, Rangareddy District, Telangana, India by MSN Laboratories
Scope: 13,296 1000-count bottles of 40 mg tablets
Recall Reason: Presence of foreign tablets/capsules.
Recall Initiation Date: October 21, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops
Drug Purpose: Over-the-counter lubricant eye drops intended for temporary relief of dry-eye burning, irritation, and discomfort, and for protection against further irritation.
Company: Huons Co., Ltd.
Manufacturing Location: Jecheon, Chungcheongbuk-do, South Korea, by Huons Col, Ltd.; marketed by GSMS Incorporated, Camarillo, California
Scope: 6,633,570 single-use tubes, from 13 lots, distributed nationwide in the United States by GSMS (Golden State Medical Supply), a supplier to military pharmacies, the U.S. federal healthcare system, and mail-order pharmacies.
Recall Reason: Failed impurities/degradation specifications; a polyethylene (PE)-related leachable compound was detected above the allowed threshold. Leaching can happen when drugs interact with plastic materials such as plastic packaging or containers. This may cause a health hazard due to potentially toxic changes in the drug’s composition. It could also affect product effectiveness.
Recall Initiation Date: October 2, 2026
Recall Level: Class II
Essential Extras: In November 2025, the FDA inspected Huons Co.’s manufacturing facility in Jecheon-si, South Korea, and identified significant violations of Current Good Manufacturing Practice (CGMP) regulations. The agency documented its findings in a Form 483, which has not been publicly released.
After determining that Huons’ response to the inspection findings was inadequate, the FDA placed the company’s products on Import Alert 66-40 on April 3, 2026. The alert allows the FDA to detain Huons’ drug products at the U.S. border without physically examining them, potentially preventing additional shipments from entering the country.
In June 2026, the FDA sent Huons a warning letter detailing deficiencies involving data integrity and cleaning and disinfection procedures. The agency warned that failure to correct the violations could result in continued refusal of its products at the U.S. border.
In August 2026, carboxymethylcellulose sodium 0.5% eye drops sold under the Walgreens, Cameron, and AvKare brands were recalled.
Link: FDA Enforcement Report
Compounded Drugs by Victory Medical Center Pharmacy: 42 individual products including GLP-1–based combinations, other peptides, vitamins, minerals, a corticosteroid, and other compounds in multi-dose vials (MDV)
Drug Purpose: Compounded drugs and supplements with different intended uses; GLP-1 combinations containing semaglutide or tirzepatide are often used for weight loss.
Company: Victory Medical Center Pharmacy, a full-service pharmacy (fills regular and compounded prescriptions)
Manufacturing Location: Austin, Texas, by Victory Medical Center Pharmacy; source of active ingredients not specified
Scope: 42 distinct multi-dose products totaling 5,918 vials distributed in Colorado, Florida, and Texas:
- Alpha Lipoic Acid, 25 mg/mL, 30 mL MDV: 10 vials.
- Ascorbic Acid, 500 mg/mL, 50 mL vials, including MDV and preservative-free formulations: 267 vials.
- B Complex, 30 mL MDV: 150 vials.
- Biotin, 10 mg/mL, 30 mL MDV: 5 vials.
- BPC-157, 5 mg/mL, 3 mL MDV: 151 vials.
- BPC-157/KPV, 5/5 mg/mL, 3 mL MDV: 30 vials.
- BPC-157/Thymosin Beta-4, 5/5 mg/mL, 3 mL MDV: 287 vials.
- Cagrilintide/Glycine/B12, 3.75/5/1 mg/mL, 1 mL MDV: 75 vials.
- CJC-1295, 2 mg/mL, 3 mL MDV: 5 vials.
- CJC-1295/Ipamorelin, 2/2 mg/mL, 2 mL and 5 mL MDVs: 146 vials.
- Dexamethasone Phosphate, 24 mg/mL, 1 mL MDV: 300 vials.
- Dexpanthenol, 250 mg/mL, 30 mL MDV: 5 vials.
- Electro B Complex, 49 mL MDV: 2,247 vials.
- GHK-Cu, 10 mg/mL, 3 mL MDV: 200 vials.
- Hydroxocobalamin, 1 mg/mL, 30 mL MDV: 20 vials.
- L-Carnitine, 500 mg/mL, 30 mL MDV: 10 vials.
- Methyl Mix, 6.25/6.25/5/6.25 mg/mL, 5 mL MDV: 190 vials.
- Methylcobalamin, 1 mg/mL in 1 mL and 30 mL MDVs, and 5 mg/mL and 12.5 mg/mL in 30 mL MDVs: 174 vials.
- MPT-141/Niacinamide, 50/2 mg/mL, 3 mL MDV: 46 vials.
- NAD+, 400 mg/mL, 5 mL MDV: 25 vials.
- Semaglutide/L-Carnitine, 2.5/25 mg/mL in 1 mL MDVs and 5/50 mg/mL in 1 mL and 3 mL MDVs: 212 vials.
- Taurine, 50 mg/mL, 30 mL MDV: 45 vials.
- Tesamorelin, 10 mg/mL, 3 mL MDV: 90 vials.
- Tesamorelin/Ipamorelin, 5/2 mg/mL, 3 mL MDV: 100 vials.
- Thymosin Alpha-1, 3 mg/mL, 5 mL MDV: 201 vials.
- Thymosin Beta-500, 10 mg/mL, 3 mL MDV: 15 vials.
- Tirzepatide/B6, 25/10 mg/mL, 1 mL and 8 mL MDVs: 114 vials.
- Tirzepatide/L-Carnitine, 10/50 mg/mL in 1 mL MDVs; 25/50 mg/mL in 1 mL, 3 mL, and 8 mL MDVs; and 30/100 mg/mL in 2 mL MDVs: 582 vials.
- Tirzepatide/Niacinamide, 20/2 mg/mL, 3 mL MDV: 208 vials.
- Zinc Sulfate, 10 mg/mL, 30 mL MDV: 8 vials.
Recall Reason: Lack of processing controls. Lack of oversight in the compounding facility could impact medication sterility, dosage accuracy, and stability.
Recall Initiation Date: October 19, 2026
Recall Level: Class II
Essential Extras: In August 2026, Victory Medical Center Pharmacy issued a Class I recall for endotoxin-contaminated glutathione compounded multi-dose vials.
Link: FDA Enforcement Report
Electric Medicated Balm Ultra Strength (menthol 16% and methyl salicylate 32%)
Drug Purpose: Over-the-counter topical pain reliever used for temporary relief of minor muscle and joint aches and pains associated with simple backache, arthritis, strains, bruises, and sprains.
Company: Fei Fah Medical Manufacturing Pte. Ltd.
Manufacturing Location: Singapore by Fei Fah Medical Manufacturing; distributed in the U.S. by Solstice Medicine Company, Los Angeles, California
Scope: 171,120 units of 70 g (2.45 ounce) and 10 g (.35 ounce) travel-size packages
Recall Reason: CGMP (Current Good Manufacturing Practice) deviations; this could affect product quality.
Recall Initiation Date: October 23, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Fludrocortisone Acetate Tablets
Drug Purpose: Corticosteroid used to treat Addison’s disease and other syndromes where excessive amounts of sodium are lost in the urine, like adrenocortical insufficiency and salt-losing adrenogenital syndrome. It is also sometimes used to treat hypotension (low blood pressure).
Company: AvKARE, Pulaski, Tennessee
Manufacturing Location: Not specified
Scope: 8,866 cartons, 50-count 0.1 mg tablets (5 × 10) per carton
Recall Reason: Failed impurities/degradation specifications; this could affect shelf life and product quality.
Recall Initiation Date: October 9, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets (generic for Tribenzor)
Drug Purpose: Three-drug combination used to treat high blood pressure, containing an angiotensin II receptor blocker, a calcium channel blocker, and a thiazide diuretic. This drug is not indicated for initial treatment of high blood pressure (hypertension).
Company: Macleods Pharma USA, Inc.
Manufacturing Location: Daman, India, by Macleods Pharmaceuticals Ltd.
Scope: 3,528 30-count bottles of 40 mg/10 mg/12.5 mg tablets; 216 90-count bottles of 40 mg/10 mg/12.5 mg tablets
Recall Reason: Failed dissolution specifications; the tablets may not dissolve as intended, potentially reducing drug effectiveness.
Recall Initiation Date: October 7, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Theophylline Extended-Release Tablets
Drug Purpose: Treats symptoms associated with chronic asthma and other chronic lung diseases like emphysema and chronic bronchitis; this medication is not for use in treating acute (sudden onset) symptoms of asthma and reversible bronchospasm.
Company: Brandywine Pharmaceuticals, LLC, West Chester, Pennsylvania
Manufacturing Location: Not specified; Brandywine Pharmaceuticals is listed as the distributor.
Scope: 1,620 100-count bottles of 100 mg tablets; 1,332 100-count bottles of 200 mg tablets
Recall Reason: Current Good Manufacturing Practice (CGMP) deviations involving an interruption in the ongoing stability testing program conducted at a third-party laboratory.
Recall Initiation Date: October 6, 2026
Recall Level: Class II
Link: FDA Enforcement Report
ValuHealth Extra Strength Pain Relief Acetaminophen Caplets, 500 mg
Drug Purpose: Over-the-counter pain reliever and fever reducer used for temporary relief of minor aches and pains.
Company: Prodose, Inc.
Manufacturing Location: India; distributed by Prodose, Inc., Ronkonkoma, New York
Scope: 100,134 40-count bottles of 500 mg caplets
Recall Reason: Incorrect label placed on product. The outer carton correctly identifies the contents as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, but the bottle label incorrectly identifies the product as ValuHealth Extra Strength Pain Relief PM.
Recall Initiation Date: October 14, 2026
Recall Level: Class III
Essential Extras: ValuHealth Extra Strength Pain Relief PM contains 500 mg of acetaminophen and 25 mg of diphenhydramine. The active ingredient in the antihistamine drug Benadryl and in some over-the-counter medications for insomnia is diphenhydramine. This recalled medication does not actually contain diphenhydramine. ValuHealth sells this product at Dollar Tree stores.
Link: FDA Enforcement Report
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