Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118...
FDA Drug Recall #D-0315-2024 — Class II — January 10, 2024
Recall Summary
| Recall Number | D-0315-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 10, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Drugs |
| Quantity | 1,786 tubes |
Product Description
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Reason for Recall
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0604-2025 | Class II | Good Neighbor Pharmacy, Alcohol Prep Pads, Dist... | Jul 7, 2025 |
| D-0601-2025 | Class II | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply... | Jul 7, 2025 |
| D-0602-2025 | Class II | ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 2... | Jul 7, 2025 |
| D-0600-2025 | Class II | Medline Alcohol Prep Pads, 70% Isopropyl Alcoho... | Jul 7, 2025 |
| D-0605-2025 | Class II | RITE AID PHARMACY, first aid alcohol prep pads,... | Jul 7, 2025 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.