The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0802-2021·Announced 2021-09-22

Betamethasone Dipropionate Lotion recalled for unknown impurity

Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to an unknown impurity found in the product that exceeds specification limits. The affected lots were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source text identifies this as an FDA Class II recall. The hazard (unknown impurity out of specification) is present but no illnesses, injuries, or deaths are reported in the source material. This is a quality/purity issue on a topical product without documented harm.

Plain-English summary

Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, in 30 mL (NDC 61748-480-30) and 60 mL (NDC 61748-480-60) bottles. The product was manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY.

The recall was initiated because testing identified an unknown impurity in the lotion that does not meet the product's established specification limits for impurities and degradation. A total of 264 bottles were distributed, including lot 372286 (48 bottles) and lot 372289 (216 bottles), both with an expiration date of 1/31/2022.

The affected product was distributed nationwide in the United States. Consumers who have obtained this product should not use it and should contact their healthcare provider or pharmacist for guidance. This is a prescription product (Rx only).

The recalled product

Product
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
Manufacturer
Akorn, Inc.
Category
Drug — Topical Lotion
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: a) 372286
  • 372289
  • Exp 1/31/2022
  • b) 372286

Distribution

Distributed nationwide across the United States.

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