Yusef Tropical Lip Moisturizer Recalled for Superpotent Meradimate Ingredient
Yusef Manufacturing Laboratories is recalling Tropical Lip Moisturizer, SPF 30, because the beginning of the batch is approximately 25% superpotent for the active ingredient Meradimate.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury reports or structural defects are Severe; while no injuries are reported, the superpotent nature of the drug ingredient warrants a higher severity than a standard Class II.
Plain-English summary
Yusef Manufacturing Laboratories, LLC is recalling Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection. The product contains the active ingredients Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, and Meradimate 5%. The recall is limited to Lot #12750 with an expiration date of 5/2021.
The recall was initiated because the beginning portion of the batch is approximately 25% superpotent for the active ingredient Meradimate. This means the concentration of Meradimate in that portion of the product is higher than the labeled amount.
The product was distributed nationwide in the United States. Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact the manufacturer for further instructions.
The recalled product
- Product
- Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA
- Manufacturer
- Yusef Manufacturing Laboratories, LLC
- Category
- Drug — Topical Sunscreen
- 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 (2)
- Lot #: 12750
- Exp 5/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Yusef Manufacturing Laboratories, LLC
See all →- ModerateRocky Mountain Sunscreen Lip Balm Recalled for Excess Octisalate
FDA (Drugs) · 2020-09-02
- ModerateYusef Recalls SPF Lip Moisturizers with Excess Oxybenzone
FDA (Drugs) · 2020-04-29
Same hazard · superpotent drug
See all →- HighLevothyroxine Sodium Tablets Recalled Due to Potency Failures
FDA (Drugs) · 2024-12-18
- SevereLupin Recalls Cefprozil Oral Suspension Due to Superpotent Drug Concerns
FDA (Drugs) · 2021-04-21
- CriticalFerring Recalls STIMATE Nasal Spray Due to Superpotent Drug Risk
FDA (Drugs) · 2020-08-26
- CriticalFerring Recalls DDAVP Nasal Spray Due to Superpotent Drug Risk
FDA (Drugs) · 2020-08-26
- CriticalAcella Recalls Superpotent NP Thyroid 15 Tablets Nationwide
FDA (Drugs) · 2020-06-10
Similar recalls
- ModerateYusef Recalls SPF Lip Moisturizers with Excess Oxybenzone
FDA (Drugs) · 2020-04-29
- ModerateRocky Mountain Sunscreen Lip Balm Recalled for Excess Octisalate
FDA (Drugs) · 2020-09-02
- ModerateJuice Beauty Lip Moisturizer recalled for failed dissolution specifications
FDA (Drugs) · 2022-08-03
- ModerateShiseido Eye and Lip Collection Recalled for GMP Deviations
FDA (Drugs) · 2018-01-24
- ModerateMilbar Recalls Malin+Goetz SPF 30 Face Moisturizer Due to GMP Deviations
FDA (Drugs) · 2020-11-25
- ModerateEcoLips Sport Lip Balm Recalled for Excessive Avobenzone Concentration
FDA (Drugs) · 2020-06-24