Medline Recalls Povidone-Iodine Prep Pads Due to Low Iodine Content
Medline Industries is recalling Aplicare Povidone-Iodine Prep Pads because the iodine content is below the labeled claim.
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 recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a subpotent drug (low iodine content), which is a labeling/potency issue rather than a contamination or acute injury risk.
Plain-English summary
Medline Industries Inc is recalling Aplicare Povidone-Iodine Prep Pads, Antiseptic, Sterile Solution. The recall involves 11,750 cases of the product, which contains Povidone-iodine USP 10% as the active ingredient. The product was distributed nationwide in the United States, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
The FDA classified this recall as Class II. The reason for the recall is that the titratable iodine contained in the prep pads is below the label claim of 0.85%. This is a subpotent drug issue, meaning the product does not contain the amount of active ingredient stated on the label.
Consumers and healthcare providers should check their inventory for the specific part numbers and lot numbers listed in the recall notice. If the product matches the recalled items, it should be removed from use and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Topical Antiseptic
- Affected units
- 11,750
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 (20)
- Part # P-1001
- Lots: 58471
- 59003
- 59723
- 60373
- 60807
- 61187
- 61523
- 61998
- 63974
- 64701
- 65864 Part # P-1001-8S Lots: 58368
- 58371
- 58472
- 58499
- 58686
- 58687
- 58688
- 58816
- 58817
Distribution
Part of a larger recall action
This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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