Akorn, Inc. recalls Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only.
Akorn recalls Clindamycin Phosphate Topical Solution 1% (Rx only) due to impurities. Products with NDC 61748-0201-60 and specific lot numbers from 2018-2019 are affected. No remedy provided in official notice.
Recall notice
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Clindamycin Phosphate Topical Solution 1% (Rx only) because impurities were found in some batches. This could pose a health risk if used as directed, but the recall does not specify a remedy. Read more at govinfonow.com/recall/39466-akorn-clindamycin-topical-solution-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/39466-akorn-clindamycin-topical-solution-recall-impurities-may-cause-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-1208-2019
Cite this page
“Akorn Clindamycin Topical Solution Recall: Impurities May Cause Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39466-akorn-clindamycin-topical-solution-recall-impurities-may-cause-harm. Based on FDA recall #D-1208-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1208-2019%22&limit=1).
Why it’s dangerous
The product contains impurities that failed quality specifications. These impurities could potentially cause harm when applied to skin, though the exact risk level is not specified in the recall notice.
Who’s affected
People with prescriptions for this topical antibiotic solution are affected. Those using the product as directed may be at risk if they have the recalled lot numbers.
How to tell if you have this one
Check the product label for the NDC number 61748-0201-60. Look for specific lot numbers: 2530200 through 2630300, all expiring by February 2019.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC number 61748-0201-60 and lot numbers 2530200 through 2630300 on the product label.
Questions people ask
Is there a remedy for this product?
The official recall notice does not provide a remedy.
What lot numbers are affected?
Lot numbers 2530200 through 2630300, all expiring by February 2019.
How can I tell if I have the recalled product?
Check the product label for NDC 61748-0201-60 and lot numbers 2530200 through 2630300.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1208-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1208-2019 from Akorn. 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-1208-2019 (October 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1208-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.