Mylan Pharmaceuticals Inc. recalls PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Mylan recalls 15mg PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets due to CGMP deviations. Affected lots expire by August 2018. Consumers should contact Mylan for details.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 15mg PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets that may have manufacturing deviations. This could affect safety, but the recall does not specify a specific risk or injury. Read more at govinfonow.com/recall/40583-mylan-prednisolone-15mg-tablets-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40583-mylan-prednisolone-15mg-tablets-recall-cgmp-deviations-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0830-2018
Cite this page
“Mylan PrednisoLONE 15mg Tablets Recall: CGMP Deviations Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40583-mylan-prednisolone-15mg-tablets-recall-cgmp-deviations-risk. Based on FDA recall #D-0830-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0830-2018%22&limit=1).
Why it’s dangerous
CGMP deviations refer to manufacturing process failures that could lead to unsafe products. However, the recall does not specify what the exact deviation is or how it might affect the medication's safety.
Who’s affected
Prescription drug users who have the specific 15mg PrednisoLONE tablets with the listed lot numbers and expiration dates. People taking this medication for conditions like arthritis or autoimmune disorders are most at risk.
How to tell if you have this one
Check for the 15mg PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets in 48-count bottles with NDC 00378-4715-22. Look for lot numbers 3082509 (expiring 08/18) or 3085901 (expiring 12/18).
- Brand
Mylan- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0829-2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22; Lot #: 3081542, Exp. 08/18 3081543, Exp. 08/18 3081544, Exp. 08/18 3082235, Exp. 08/18 3085903, Exp. 12/18 3088974, Exp. 06/19 3090445, Exp. 06/19 | 7,334 48-count bottles |
| D-0830-2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22; Lot #: 3082509; Exp. 08/18 3085901; Exp. 12/18 | 9,906 48-count bottles |
| D-0831-2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22; Lot #: 3082921; Exp. 12/18 3088975; Exp. 06/19 | 3,844 48-count bottles |
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the packaging to confirm if your tablets are affected.
Questions people ask
Is this product safe to use?
The recall does not specify a safety risk, but the CGMP deviations indicate potential manufacturing issues that may affect safety.
How can I get a replacement?
The recall does not mention any remedy or replacement options.
What should I do if I have the affected product?
The recall does not specify a remedy, so contact Mylan directly for guidance.
Contact Mylan
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0830-2018 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0830-2018 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0830-2018 (April 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0830-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.