The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0828-2021·Announced 2021-09-29

Betadine Povidone-Iodine Solution Swabstick recalled for subpotent drug

Avrio Health L.P. is recalling Betadine Solution Swabstick in single and three-count packages nationwide because the product is subpotent—meaning it contains less active ingredient than specified. Consumers should stop using affected lots and consult their healthcare provider if needed.

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: This is an FDA Class II recall initiated voluntarily by the firm. The hazard is subpotency (reduced active ingredient), which does not involve contamination or high-risk pathogens, and no illnesses or injuries are reported. This aligns with the Moderate category for a Class II recall without reported harm.

Plain-English summary

Avrio Health L.P. is voluntarily recalling Betadine Solution Swabstick Povidone-Iodine Solution USP, 10%, distributed nationwide. The recall affects both single and three-count antiseptic swabstick packages with NDC 67618-153-01 and NDC 67618-153-03. The product is being recalled because it is subpotent—the active pharmaceutical ingredient (povidone-iodine) is present in lower amounts than the labeled 10% concentration.

The affected lots are: 11901232, 11901549, 12000585, 12000964, 12001457, 12002142, 12100407, 11901231, 11901548, 12000584, 12000963, 12001185, 12001456, 12002150, and 12100406. Expiration dates range from September 2021 through March 2023. A total of 75,828 shippers were distributed.

Consumers who have purchased affected Betadine Solution Swabstick should stop using the product. Those who have used the product and have concerns about its effectiveness should contact their healthcare provider. Consumers may return the product to the place of purchase. Healthcare providers and patients can report adverse events to the FDA at 1-888-SAFEFDA or online at www.fda.gov/medwatch.

The recalled product

Product
BETADINE (POVIDONE-IODINE)
Brand
BETADINE
Manufacturer
AVRIO HEALTH L.P
Category
Drug — Topical Antiseptic
Hazard
Affected units
75,828

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 (16)

  • Lot # 11901232
  • Exp. Date 09/30/2021 11901549
  • Exp. Date 11/30/2021 12000585
  • Exp. Date 03/31/2022 12000964
  • Exp. Date 5/31/2022 12001457
  • Exp. Date 7/31/2022 12002142
  • Exp. Date 12/31/2022 12100407
  • Exp. Date 03/31/2023 11901231
  • Exp. Date 09/30/2021 11901548
  • Exp. Date 11/30/2021 12000584
  • Exp. Date 03/31/2022 12000963
  • Exp. Date 05/31/2022 12001185
  • Exp. Date 06/30/2022 12001456
  • Exp. Date 07/31/2022 12002150
  • Exp. Date 12/31/2022 12100406
  • Exp. Date 03/31/2023

Distribution

Distributed nationwide across the United States.

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