Teligent Pharma recalls Hydrocortisone Butyrate Lotion 0.1% 4 fl oz bottles due to cGMP deviations. All products within expiry are being recalled as the firm discontinues its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% 4 fl. oz. bottles because the manufacturer discontinued its stability testing program. This recall affects prescription-only products distributed by Mayne Pharma.
The recall is due to cGMP deviations, meaning the manufacturer stopped its stability testing program. This could affect the product's safety and effectiveness over time, though no specific harm has been reported.
Prescription holders of Hydrocortisone Butyrate Lotion 0.1% 4 fl. oz. bottles distributed by Mayne Pharma in Greenville, NC. Patients using this medication are most at risk due to the recall.
Check for the 4 fl. oz. (118 mL) Hydrocortisone Butyrate Lotion 0.1% bottle with NDC 51862-159-04. Batch numbers 15435 (expiring 3/31/2022) or 16960 (expiring 5/31/2023) are included in the recall.
Identify the product by checking the NDC number 51862-159-04 and batch numbers 15435 or 16960.
The manufacturer discontinued its stability study program, leading to cGMP deviations. All products within expiry are being recalled.
The recall is due to cGMP deviations, but no specific safety risks or injuries have been reported.
Check for the 4 fl. oz. Hydrocortisone Butyrate Lotion 0.1% bottle with NDC 51862-159-04 and batch numbers 15435 (expiring 3/31/2022) or 16960 (expiring 5/31/2023).
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0690-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0690-2022 from Teligent Pharma. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
