CLASS II Drug recall · Reported 22 Aug 2018 · FDA Enforcement Report
alba Botanica Sensitive Sheer Shield Sunscreen Fragrance recalled
The Hain Celestial Group Inc. - Worldwide HQ is recalling alba Botanica Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ tube, distributed in California. The recall was initiated on 25 Jul 2018 and the FDA has classified it as Class II.
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-1078-2018
- FDA event ID
- 80648
- Recalling firm
- The Hain Celestial Group Inc. - Worldwide HQ, New Hyde Park, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2018
- FDA classified
- 14 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Sunscreen & Personal Care
Timeline
| 25 Jul 2018 | Recall initiated by company | |
| 14 Aug 2018 | Classified by FDA | +20 days |
| 22 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of a Non-Sterile Product
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
Where it was distributed
Product was distributed to one distributor in California who may have distributed the product further within the US.
Questions about this recall
Why was it recalled?
Microbial Contamination of a Non-Sterile Product
Which lots are affected?
Lot code 8041
Where was it sold?
Product was distributed to one distributor in California who may have distributed the product further within the US.
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.
More recalls from The Hain Celestial Group Inc. - Worldwide HQ
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | alba Botanica sport mineral sunscreen recalled | The Hain Celestial Group Inc. - Worldwide HQ | Packaging Defects | Nationwide |
| Food | CLASS III | BluePrint Organic Beet Blast Vegetable & Fruit Drink USDA Organic recalledBluePrint | The Hain Celestial Group Inc. - Worldwide HQ | Packaging Defects | 13 states |
| Food | CLASS I | MaraNatha¿ All Natural Sunflower Seed Butter recalledMaraNatha | The Hain Celestial Group Inc. - Worldwide HQ | Listeria | Nationwide |