SUN PHARMACEUTICAL INDUSTRIES INC recalls Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Sun Pharma recalls 8mg buprenorphine sublingual tablets due to CGMP deviations. Affected lots may have quality issues affecting safety.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Sun Pharma is recalling 8mg buprenorphine sublingual tablets (30-count) that were manufactured with CGMP deviations. This recall is for safety reasons due to potential quality issues in the production process. Read more at govinfonow.com/recall/33498-sun-pharma-buprenorphine-tablets-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33498-sun-pharma-buprenorphine-tablets-recall-cgmp-deviations-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0869-2023
Cite this page
“Sun Pharma Buprenorphine Tablets Recall: CGMP Deviations Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33498-sun-pharma-buprenorphine-tablets-recall-cgmp-deviations-risk. Based on FDA recall #D-0869-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0869-2023%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in the manufacturing process that could affect product quality. This may lead to potential safety issues with the medication.
Who’s affected
Prescription holders of the 8mg buprenorphine sublingual tablets (30-count) with lot number DND1515A. Patients using these specific tablets are most at risk.
How to tell if you have this one
Check for the product name 'Buprenorphine Sublingual Tablets, 8 mg, 30 count' with lot number DND1515A and expiration date 08/24.
- Brand
Sun Pharma- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the product label to confirm if it matches DND1515A expiring 08/24.
Questions people ask
Is this product safe to use?
The recall is due to CGMP deviations, which may affect product quality. The official notice does not specify if the product is safe to use.
How can I check if my product is affected?
Check the lot number on the product label; affected items have lot number DND1515A with expiration 08/24.
What should I do if I have this product?
The recall does not specify a remedy, so the official notice does not state what action to take.
Contact Sun Pharma
We’ve drafted a message you can send Sun Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0869-2023 — Sun Pharma Sun Pharma Hello, I own a Sun Pharma that is covered by recall D-0869-2023 from Sun 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.
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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-0869-2023 (May 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0869-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.