Class II · Moderate risk
Karina Daily Moisturizer SPF 25
CGMP Deviations
LA FRESH travel lite Sunnyside Lotion Wipe silky
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine, Phenoxyethanol, Distributed by La Fresh Group, Inc. Chino, CA 91710 www.LaFreshGroup.com
Drug: Octinoxate
- Recalling firm
- La Fresh Group, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1566-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Octinoxate recalls
See all
Class II · Moderate risk
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
Sea Enzyme Ultra Umbrella Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
(Malin+Goetz) spf 30 face moisturizer
GMP Deviations
Class II · Moderate risk
Tropical Lip Moisturizer
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Other unapproved drug recalls from 2019
All unapproved drug recalls
Class I · High risk
Panther Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Rhino 7 Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Stallion Platinum 30000 Capsules in blue
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Bull Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.