CLASS III Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report
Options Rx Anti-Oxidant Oil-Free Sunscreeen recalled by CBI Laboratories
CBI Laboratories is recalling Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone. The recall was initiated on 10 Dec 2018 and the FDA has classified it as Class III.
Check your package
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.
Recall details
- Recall number
- D-0342-2019
- FDA event ID
- 81775
- Recalling firm
- CBI Laboratories, Fort Worth, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Dec 2018
- FDA classified
- 20 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 10 Dec 2018 | Recall initiated by company | |
| 20 Dec 2018 | Classified by FDA | +10 days |
| 26 Dec 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
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
Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
Where it was distributed
United States, Maldives, Canada, United Arab Emirates, and New Zealand
Questions about this recall
Why was it recalled?
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Which lots are affected?
Lot #: 129114 Exp. 06/2019; 131927,133239 Exp. 03/2020; 126292, Exp.01/2019.
Where was it sold?
United States, Maldives, Canada, United Arab Emirates, and New Zealand
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
1 other product · FDA event 81775This product is part of a recall event; the main page for the event is Advanced Protection Sunscreen spf 30 (Octinoxate recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Advanced Protection Sunscreen spf 30 (Octinoxate recalled | CBI Laboratories | Potency & Assay | TX |
More recalls from CBI Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Advanced Protection Sunscreen spf 30 (Octinoxate recalled | CBI Laboratories | Potency & Assay | TX |