CLASS IIDrug recall · Reported 24 Oct 2018 · FDA Enforcement Report
dr. brandt, BB cream with signature Flexitone, SPF 30 tube recalled
Product Quest Manufacturing is recalling dr. brandt, BB cream with signature Flexitone, SPF 30 tube, distributed nationwide in the US. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesLot: 161223D, Exp. 4/16/2019
Quantity recalled9,480 tubes
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: separation of product and failure for actives.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
Failed Stability Specifications: separation of product and failure for actives.
Which lots are affected?
Lot: 161223D, Exp. 4/16/2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.