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.
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
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.
The lotion contains an unknown impurity that failed quality specifications. This could potentially cause health issues, though the exact risk is not clearly defined in the recall notice. The impurity may be harmful if the medication is used without proper medical guidance.
People with a prescription for this medication who received the recalled lot numbers (372286, 372289) from Hi-Tech Pharmacal Co. Inc. in Amityville, NY. Those using the lotion without medical supervision are at higher risk.
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.
Look for the NDC codes 61748-480-30 or 61748-480-60 and lot numbers 372286 or 372289 with expiration 1/31/2022.
The recall states the product contains an unknown impurity that failed quality specifications, but the exact health risk is not clearly defined. Consult your doctor for guidance.
Check for the 30mL or 60mL bottles with NDC codes 61748-480-30 or 61748-480-60 and lot numbers 372286 or 372289 that expire 1/31/2022.
The recall does not specify a remedy, so contact Akorn directly for instructions on what to do with the product.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0802-2021 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0802-2021 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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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.
