Unrated Drug recall · FDA · Published August 13, 2021

Akorn Betamethasone Lotion Recall: Unknown Impurity Risk

Akorn recalls 0.05% Betamethasone Dipropionate Lotion USP (Augmented) due to an unknown impurity. This topical medication, sold in 30mL and 60mL bottles, may pose health risks. Consumers should contact Akorn for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0802-2021Drug Akorn ›

Recall notice

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Take action

Contact the company

Recalling firmAkorn, Inc.1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862

✎ GovInfoNow plain-language explainer

Akorn is recalling 0.05% Betamethasone Dipropionate Lotion USP (Augmented) in 30mL and 60mL bottles because it contains an unknown impurity that could be harmful. This medication is prescription-only and may cause health risks if used without proper medical supervision. Read more at govinfonow.com/recall/35976-akorn-betamethasone-lotion-recall-unknown-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35976-akorn-betamethasone-lotion-recall-unknown-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0802-2021

Cite this page

“Akorn Betamethasone Lotion Recall: Unknown Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35976-akorn-betamethasone-lotion-recall-unknown-impurity-risk. Based on FDA recall #D-0802-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0802-2021%22&limit=1).

The FDA announced on 2021-08-13 that Akorn, Inc. voluntarily recalled Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to failed impurity specifications. The recall affects products distributed nationwide in the USA.

How to tell if you have it

Brand: Akorn
Product: Betamethasone Dipropionate Lotion USP (Augmented), 0.05%
NDC 61748-480-30 (30 mL bottle)
NDC 61748-480-60 (60 mL bottle)
Lot #: 372286, 372289
Expiration: 1/31/2022
Manufacturer: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701

The hazard

The product failed impurities/degradation specifications, specifically showing out-of-specification results for an unknown impurity observed in the topical product.

Context

GovInfoNow's records show Akorn, Inc. has 64 other recalls on record since 2014-08-05. Other recent recalls of similar products include Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (2025-12-30), Somerset Therapeutics Dexamethasone Injection Recall (2026-02-04), and Sagent Busulfan Injection Recall (2026-05-04).

How to tell if you have this one

Check for the 30mL or 60mL bottles labeled with NDC 61748-480-30 or 61748-480-60. The lot numbers 372286 or 372289 with expiration date 1/31/2022 are part of the recall.

Brand
Akorn
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC codes 61748-480-30 or 61748-480-60 and lot numbers 372286 or 372289 with expiration 1/31/2022.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Aug 13, 2021Firm started the recall
Sep 16, 2021FDA classified it Class II
Sep 22, 2021Published in FDA’s Enforcement Report
Aug 17, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35976-akorn-betamethasone-lotion-recall-unknown-impurity-risk">Akorn Betamethasone Lotion Recall: Unknown Impurity Risk (GovInfoNow)</a>

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-0802-2021 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0802-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.