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 a fentanyl patch, an herbal dietary supplement with undeclared ingredients, and Prograf and Astagraf capsules.
This installment also highlights warnings that were issued to two websites selling unapproved drugs and for manufacturing violations by generics manufacturers Mylan, Akron and Indoco.
Also included is a warning letter directed at Sanofi because of violations at its U.S.-based biological pharmaceuticals manufacturing facility.
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. This report is written using three resources:
Recalls
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
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.
A warning letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.
Drug Imports Alerts
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
Fentanyl Transdermal System 25 mcg/h transdermal patches
Company: Alvogen, Inc. (distributor)
Manufacturer: Kindeva Drug Delivery L.P., Northridge, CA
Drug Purpose: Used for management of severe and persistent pain in opioid-tolerant patients.
Recall Reason: There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Risk Statement: This could result in serious, life threatening, or fatal respiratory depression.
Recall Date: January 31, 2025
FDA Press Release
See FDA press release for affected lot number and product images.
Prograf 0.5mg (Tacrolimus) and Astagraf XL 0.5mg (Tacrolimus Extended-Release Capsules)
Company: Astellas Pharma US, Inc.
Drug Purpose: Prevents rejection of an organ transplant such as kidney, heart, or liver.
Recall Reason: Bottles shipped to U.S. may contain empty capsules
Risk Statement: Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to under immunosuppression.
Recall Date: December 23, 2024
Impact of Recall: Sufficient supply of unaffected stock is available to replace the recalled lots.
FDA Press Release
See FDA press release for affected lot numbers and expiration dates.
Dietary Supplement Recalls
Fouzee SugarLin Herbal Formula
Company: Shoppers-Plaza
Supplement Purpose: Promoted and sold as a blood sugar support supplement for “healthy weight management” and “healthy energy levels.”
Where It’s Sold: Sold nationally at online websites including www.shoppers-plaza.com and possibly in some retail stores.
Recall Reason: Product contains undeclared Metformin and Glyburide. Both are ingredients in prescription drugs used to treat Type 2 diabetes.
Risk Statement: Metformin can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death if untreated. Glyburide may result in unsafe drops in blood sugar levels (hypoglycemia).
Recall Date: December 16, 2024
FDA Recall Announcement
See FDA press release for product photos and more information.
FDA Warning Letters: Unapproved Drugs for Sale Online
Xcel Research LLC
Warning Date: December 10, 2024
Location: Sheridan, WY
Types of Products Sold: Unapproved GLP-1 products
Type of Warning: Unapproved New Drugs/Misbranded
FDA Warning: The website says the drugs it is selling are for research purposes but the FDA asserts they are clearly for human use. These products have not been approved by the FDA.
FDA Warning Letter
www.weightcrunchshop.com
Warning Date: January 13, 2025
Location: Hong Kong SAR China
Types of Products Sold: Unapproved and misbranded semaglutide and opioid drug products
Type of Warning: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
FDA Warning Letter
FDA Warning Letters: Facility Inspections
Genzyme (a Sanofi subsidiary)
Warning Letter Date: January 15, 2025
Facility Location: Framingham, Massachusetts
FDA Warning: Multiple manufacturing violations, including failure to adequately investigate a cause of contamination. “FDA documented that approximately 20 percent of bioreactor runs attempted between January 2022 and July 2024 were rejected for contamination or other quality failures. This rate is excessive and calls into question the state of control of your process. You failed to conduct adequate investigations into critical deviations, including multiple microbiological contamination events recorded in this timeframe.“ The facility’s bioreactor is the vessel used to grow organisms and cells.
Types of Products Made: Specific products are not identified. The facility makes biological medicines in Sanofi’s Specialty Care portfolio.
Example products: Possible medications from the Specialty Portfolio that might be made at this facility include the FDA-approved biological drug Fabrazyme (agalsidase beta), an enzyme replacement therapy for Fabry Disease, and Cerezyme (imiglucerase) an enzyme replacement therapy for Gaucher disease.
Essential Extras: Sanofi’s digital “paperless” manufacturing facility opened in Framingham in October 2019 and won the 2020 Facility of the Year Award in the “Facility of the Future” category from the International Society for Pharmaceutical Engineering.
Link: FDA Warning Letter
Read the warning letter for specific details about the violations.
Indoco Remedies Ltd
Date of Letter: December 16, 2024
Facility Location: Mumbai, India
FDA Warning: During a facility inspection between July 16 and 26, 2024, the FDA found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Types of Products Made: Specific products are not identified. The facility makes generic pharmaceuticals.
Link: FDA Warning Letter
Read the warning letter for specific details about the violations.
FDA Warning Letters: Import Bans
Viatris (Mylan Laboratories)
Warning Letter Date: December 19, 2024
Facility Location: Madhya Pradesh, India
FDA Warning: Significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Types of Products Made: Generic pharmaceuticals. Specific products are not identified.
Import Ban: The FDA placed 11 products from this facility on an import ban list (Import Alert 66-40) on December 19, 2024. This means the drugs may no longer be brought into the U.S. and offered for sale until the FDA takes them off the Import Alert. Specific products are not identified other than the names of four products exempt from the import ban due to a shortage: Levothyroxine Sodium Tablets, Fingolimod Capsules, Atorvastatin Calcium Tablets, Metformin Hydrochloride Tablets.
Link: FDA Warning Letter and Viatris Press Release
Read the warning letter for specific details about the violations.
Akron Manufacturing
Warning Letter Date: December 17, 2024
Facility Location: Hyderabad, Telangana India
FDA Warning: Significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Types of Products Made: Over-the-counter drug products.
Related Recall: Voluntary recall of OneLAX Docusate Sodium Liquid Stool Softener Laxative on 10/15/2024
Import Ban: The FDA placed products from this facility on an import ban list (Import Alert 66-40) on November 26, 2024. This means that products originating from this facility may no longer be brought into the U.S. and offered for sale until the FDA takes them off the Import Alert.
Link: FDA Warning Letter and FDA Enforcement Report Recall Link
Read the warning letter for specific details about the violations.
