First Aid Antiseptic Ointment Recalled for Mislabeled Inactive Ingredients
Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment because the product contains undeclared inactive ingredients not listed on the label.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product where inactive ingredient mislabeling could affect individuals with sensitivities or requirements regarding these ingredients. The substitution of polyethylene glycol for the labeled mineral oil and petrolatum in a topical product poses a potential risk. No illnesses or injuries have been reported, which applies the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment manufactured by Zhejiang Jingwei Pharmaceutical Co., Ltd. The product is a topical antiseptic available in 1 oz (28.4 g) tubes with NDC 0536-1271-80.
The recall was initiated because the inactive ingredients in the actual product differ from what is labeled on the product boxes and tubes. The labeled ingredients state "mineral oil, petrolatum," but the actual product contains polyethylene glycol 400 and polyethylene glycol 4000. This mislabeling could affect individuals who avoid or have sensitivities to these ingredients.
The affected product was distributed through one wholesaler in Ohio for nationwide distribution. A total of 295,164 tubes are affected, with lot numbers and expiration dates: Lot 220901 (Exp. 09/30/2024), Lot 230701 (Exp. 07/31/2026), Lot 230301 (Exp. 03/31/2026), Lot 230401 (Exp. 04/30/2026), Lot 230501 (Exp. 05/31/2026), Lot 230801 (Exp. 08/31/2026), Lot 240301 (Exp. 03/31/2027), and Lot 240501 (Exp. 04/30/2027).
Consumers should stop using this product if they have sensitivities to polyethylene glycol or prefer to avoid it. Contact Rugby Laboratories or the FDA if you have questions or believe you have been affected by this recall.
The recalled product
- Product
- FIRST AID ANTISEPTIC (POVIDONE-IODINE)
- Brand
- FIRST AID ANTISEPTIC
- Manufacturer
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Affected units
- 295,164
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 (17)
- Lot
- expiry: Lot 220901
- Exp. 09/30/2024
- Lot 230701
- Exp. 07/31/2026
- Lot 230301
- Exp. 03/31/2026
- Lot 230401
- Exp. 04/30/2026
- Lot 230501
- Exp. 05/31/2026
- Lot 230801
- Exp. 08/31/2026
- Lot 240301
- Exp. 03/31/2027
- Lot 240501
- Exp. 04/30/2027.
UPCs (1)
- 0305361271800
Distribution
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