As of this article’s publication, updates to the FDA’s Drug Safety Database appear to be coming in much slower than usual. To learn more about the reasons behind the delay, see our article: Medication Safety Updates from the FDA Delayed.
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 recalls for haloperidol decanoate, duloxetine, and clomipramine.
This installment also highlights FDA warnings about unapproved hair loss medications sold at telehealth websites, arthritis supplements with undeclared and potentially dangerous ingredients, and fraudulent Ozempic.
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. 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
Clomipramine Hydrochloride (generic for Anafranil)
Company: Lupin Pharmaceuticals
Manufacturing Location: Nagpur, India
Drug Description: Treats obsessive compulsive disorder (OCD) and depression.
Scope: 2,724 bottles (25 mg, 100-count)
Recall Reason: Failed degradation test during 18-month drug stability study. This could affect drug quality and the accuracy of expiration dates.
Recall Initiation Date: April 10, 2025
Link: FDA Enforcement Report
This recall is directed at retail suppliers, not consumers. This means retailers are instructed to remove products from store shelves and online marketplaces but does not specifically instruct consumers to take actions regarding products currently in their possession.
Duloxetine Delayed-Release Capsules (generic for Cymbalta)
Company: Breckenridge Pharmaceutical, Inc.
Manufacturing Location: Towa Pharmaceutical Europe S.L., Barcelona, Spain
Drug Description: Treats depression.
Scope: 343,344 bottles (30mg: 90 and 1,000 count); 16,473 bottles (60 mg 1,000 count)
Recall Reason: Nitrosamine substance above the proposed limit.
Risk Statement: High levels of nitrosamine impurities, which happen during the manufacturing process, can increase the risk of cancer.
Recall Initiation Date: April 14, 2025
Link: FDA Enforcement Report
This recall is directed at retail suppliers, not consumers. This means retailers are instructed to remove products from store shelves and online marketplaces but does not specifically instruct consumers to take actions regarding products currently in their possession.
Haloperidol Decanoate for Intramuscular Injection (generic for Haldol Decanoate)
Company: Amerisource (distributor) and Somerset Therapeutics for BluePoint Laboratories
Manufacturing Location: Karnataka, India
Drug Description: Long-acting antipsychotic for treating schizophrenia; sometimes used off-label in hospitals and other healthcare facilities for agitation. This medication is administered by a healthcare professional.
Scope: 8,053 vials (50 mg); 38,532 vials (100 mg)
Recall Reason: Lack of assurance of sterility and bacterial contamination.
Recall Initiation Date: March 21, 2025 and April 2, 2025
Link: FDA Enforcement Report (April 2) and FDA Enforcement Report (March 21)
This recall is directed at suppliers, not consumers.
FDA Safety Alerts and Warnings
Counterfeit Ozempic (semaglutide) for subcutaneous injection
Company: Unknown
Drug Description: Treats diabetes.
Reason for Warning: FDA and Novo Nordisk report that several hundred units of counterfeit Ozempic (semaglutide) injections (1mg) were seized from the U.S. drug supply chain. Consumers and pharmacies are warned to check that the Ozempic they have purchased is an authentic product.
Risk Statement: FDA and Novo Nordisk are testing the seized products and do not yet have information about the source, quality, or safety of these drugs. Additionally, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products.
Essential Extras: Consumers and retailers should not use, distribute or sell products labeled with lot number PAR0362 and serial number starting with the first eight digits 51746517.
Announcement Date: April 14, 2025
Link: FDA Warning Statement about Counterfeit Ozempic and Novo Nordisk press release
FDA and company press releases have more information and product images, including photos of packaging and counterfeit needles.
Finasteride Topical Spray Hair Loss Treatment
Company: Various online telehealth platforms like Roman, Keeps, and Hims & Hers.
Drug Description: Used as a treatment for hair loss in men.The online products are compounded (custom made) with finasteride and sometimes also contain minoxidil (used in Rogaine) and tretinoin (ingredient used in the skin treatment Retin-A).
Risk Statement: The FDA warns consumers, health care providers, and compounders about potential risks from topical finasteride-containing treatments for male hair loss. Users have reported side effects including depression, fatigue, insomnia, dizziness, and low libido. These are side effects similar to those associated with the approved finasteride prescription tablets. The FDA notes that the topical formulation, which could be transferred to others through skin contact, could be especially dangerous to pregnant women because of the potential to cause abnormalities in a male fetus.
Essential Extras: FDA-approved versions of finasteride include Propecia tablets for treating male hair loss and Proscar tablets for treating symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. No topical versions of finasteride are FDA-approved.
Announcement Date: April 22, 2025
Link: FDA Warning about Topical Finasteride
Supplement: Painflex Forte
Company: NaTerra
Product Description: Marketed for treating arthritis and joint pain.
Where Sold: Product is sold at various websites, including Amazon, ibspot.com and possibly in some retail stores.
FDA Warning: FDA laboratory analysis confirmed that Painflex Forte contains these active drug ingredients not identified on the label: dexamethasone (corticosteroid) and diclofenac (non-steroidal anti-inflammatory drug (NSAID). This product may be harmful because of the hidden drug ingredients. Read the press release for details and product images.
Essential Extras: Painflex Forte joins the FDA’s growing list of pain and arthritis supplements tainted with hidden ingredients.
Warning Date: April 23, 2025
Link: FDA Press Release on Painflex Forte
An official FDA warning letter has not yet been posted in the Warnings Letters Database, but based on other similar products with undeclared ingredients, this company will likely receive an official FDA warning letter for an “Unapproved New Drugs/Misbranded” violation.
Supplement: Artrifan King
Company: Artriking
Product Description: Marketed for treating arthritis and joint pain.
Where Sold: Product is sold at various Spanish-language online supplements stores (such as Walmart and Amazon in Mexico) and the U.S., including www.artriking.us, and possibly in some retail stores.
FDA Warning: FDA laboratory analysis confirmed that Artrifan King contains active drug ingredients not identified on the label: dexamethasone (corticosteroid), diclofenac (non-steroidal anti-inflammatory drug (NSAID), and methocarbamol (a muscle relaxant). This product may be harmful because of the hidden drug ingredients. The FDA press release contains specific details about potential harms.
Essential Extras: Since January 2022, the FDA has issued multiple warnings for products with the Artri and Ortiga names. Adverse event reports of liver toxicity and death have been associated with the use of Artri King, Ortiga, and similarly named products. Artrifan King is on the FDA’s growing list of pain and arthritis supplements tainted with hidden ingredients.
Warning Date: April 25, 2025
Link: FDA Press Release on Artrifan King
An official FDA warning letter has not yet been posted in the Warnings Letters Database, but based on other similar products with undeclared ingredients, this company will likely receive an official FDA warning letter for an “Unapproved New Drugs/Misbranded” violation.
