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Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications FDA Recalls and Warnings: Hormones Found in Toothpaste; ADHD Drug May Not Dissolve Properly
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Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions
November 12, 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 ciprofloxacin, lisdexamfetamine, metoprolol tartrate, ORL Organic Oral Care Natural Toothpaste and Mouthwash, and Tychasis Coats Aloe Lotion, Creme, and Liniment.
Consumers may wish to check the linked enforcement report for the list of 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
Ciprofloxacin Tablets (generic for Cipro)
Drug Purpose: Fluoroquinolone antibiotic used to treat adults with certain bacterial infections, including complicated urinary tract and kidney infections, skin infections, bone and joint infections, and lower respiratory tract infections. In children ages 1 to 17, ciprofloxacin is approved to treat complicated urinary tract and kidney infections caused by certain bacteria, as well as for anthrax exposure and plague.
Company: Hikma Pharmaceuticals USA Inc.
Manufacturing Location: Amman, Jordan, by Hikma Pharmaceuticals
Scope: 29,085 100-count bottles of 500 mg tablets distributed nationwide in the U.S.
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: October 20, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Lisdexamfetamine Dimesylate Capsules (generic for Vyvanse)
Drug Purpose: Treats Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; treats moderate to severe binge eating disorder in adults. Lisdexamfetamine is a DEA Schedule II drug, which means it has a high risk for misuse and potential for addiction.
Company: Sun Pharmaceutical Industries, Inc.
Manufacturing Location: New Brunswick, New Jersey, by Ohm Laboratories; distributed by Sun Pharmaceutical Industries, Inc., Cranbury, New Jersey
Scope: 17,760 100-count bottles of 40 mg capsules distributed in Ohio and Mississippi
Recall Reason: Failed dissolution specifications; the tablets may not dissolve as intended, potentially reducing drug effectiveness.
Recall Initiation Date: October 21, 2026
Recall Level: Class II
Link: FDA Enforcement Report
Metoprolol Tartrate Tablets (generic for Lopressor)
Drug Purpose: Beta blocker used to treat high blood pressure and angina (chest pressure or pain)
Company: Advagen Pharma Limited
Manufacturing Location: Not specified in Enforcement Report; label states it was made in Thane, India, by Rubicon Research; distributed by Advagen Pharma Ltd., East Windsor, New Jersey
Scope: 3,684 1000-count bottles of 50 mg tablets
Recall Reason: Presence of foreign tablets/capsules
Recall Initiation Date: October 27, 2026
Recall Level: Class II
Link: FDA Enforcement Report
ORL Organic Oral Care Natural Toothpaste and ORL Organic Oral Care Mouthwash (6 products)
Product Purpose: Oral care products intended for cleaning teeth and rinsing the mouth. The toothpaste label describes the product as a “Hydroxyapatite Toothpaste, Fluoride-Free, with Organic Xylitol.”
Company: ORL Labs LLC, Scottsdale, Arizona
Manufacturing Location: USA
Scope: 30,925 toothpaste products and 21,337 mouthwash products distributed nationwide in the U.S.:
- ORL Organic Oral Care Bubblegum Kids Natural Toothpaste, 4 oz: 3,976 units
- ORL Organic Oral Care Cinnamint Toothpaste, 4 oz.: 7,702 units
- ORL Organic Oral Care Fresh Mint Natural Toothpaste, 4 oz.: 19,247 units
- ORL Organic Oral Care Cinnamint Kids Mouthwash, 16.9 oz: 6,140 units
- ORL Organic Oral Care Bubblegum Kids Mouthwash, 16.9 oz: 3116 units
- ORL Organic Oral Care Fresh mint mouthwash, 16.9 oz.: 12,081 units
Recall Reason: Cross-contamination. FDA testing of samples detected progesterone, estradiol, or dehydroepiandrosterone (DHEA). Progesterone and estradiol are female hormones used in oral contraceptives or as hormone replacement therapy (HRT) during menopause. DHEA is a hormone made by the adrenal glands and is used in supplements for adrenal insufficiency or anti-aging benefits. DHEA can also increase the level of steroid hormones such as testosterone.
Recall Initiation Date: October 12, 2026
Recall Level: Class II
Essential Extras: In December 2025, Signature Formulations, LLC, a manufacturer of ORL products, recalled ORL kids bubblegum toothpaste and mouthwash due to potential contamination with exogenous hormones. In January 2026, the company received an FDA warning letter citing Current Good Manufacturing Practice (CGMP) violations, including inadequate separation of manufacturing areas to prevent cross-contamination. Signature Formulations also makes health supplements, including vitamins and bioidentical hormones (progesterone and estrogen). As of November 10, 2026, the ORL website states it is “currently undergoing site maintenance and will temporarily be pausing all orders.”
Link: FDA Enforcement Report
Tychasis Coats Aloe Lotion, Creme, and Liniment
Drug Purpose: Tychasis Coats Aloe Lotion and Creme are over-the-counter skin protectants containing 0.5% allantoin. They temporarily protect minor cuts, scrapes, and burns and help relieve chafed, chapped, or cracked skin. Tychasis Coats Aloe Liniment is an over-the-counter topical pain reliever containing 10% methyl salicylate, used to temporarily relieve minor muscle and joint aches and pains.
Company: BioMed Laboratories, LLC
Manufacturing Location: Dallas, Texas for Tychasis Corporation, Dallas, Texas
Scope: 12,028 4 oz and 16 oz jars of Tychasis Coats Aloe Creme distributed in Texas only; 13,128 0.5 oz, 8 oz, and 33 oz bottles of Tychasis Coats Aloe Lotion distributed in Texas only; 11,130 bottles of 0.5 oz, 8 oz, and 33 oz Tychasis Coats Aloe Liniment distributed in Texas only.
Recall Reason: Failed stability specifications. Out-of-specification stability results for viscosity and appearance did not meet established product specifications. The product might be too thick or thin for ease of application.
Recall Initiation Date: October 15, 2026
Recall Level: Class II
Link: FDA Enforcement Report
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