CLASS III Drug recall · Reported 23 Aug 2017 · FDA Enforcement Report
Beautipharm Eye Care Balm SPF 10 (Octocrylene recalled
Linde Eckstein Gmbh + Co KG is recalling Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, distributed nationwide in the US. The recall was initiated on 17 Jul 2017 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-1099-2017
- FDA event ID
- 77840
- Recalling firm
- Linde Eckstein Gmbh + Co KG, Oberasbach, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Jul 2017
- FDA classified
- 17 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 Jul 2017 | Recall initiated by company | |
| 17 Aug 2017 | Classified by FDA | +31 days |
| 23 Aug 2017 | 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: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
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
Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.
Where it was distributed
Distributed throughout the United States
Questions about this recall
Why was it recalled?
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Which lots are affected?
Lot #: 280318, Exp 03/28/2018; 020918, Exp 09/02/2018; 131019, Exp 10/13/19
Where was it sold?
Distributed throughout the United States
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 21 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
13 other products · FDA event 77840This product is part of a recall event; the main page for the event is Beautipharm Body Moisturizing Balm SPF recalled.
More recalls from Linde Eckstein Gmbh + Co KG
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up recalled | Linde Eckstein Gmbh + Co KG | Potency & Assay | Nationwide |
| Drug | CLASS III | Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up recalled | Linde Eckstein Gmbh + Co KG | Potency & Assay | Nationwide |
| Drug | CLASS III | Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up recalled | Linde Eckstein Gmbh + Co KG | Potency & Assay | Nationwide |
| Drug | CLASS III | Beautipharm All Day Moisturizing Balm SPF recalled | Linde Eckstein Gmbh + Co KG | Potency & Assay | Nationwide |
| Drug | CLASS III | Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up recalled | Linde Eckstein Gmbh + Co KG | Potency & Assay | Nationwide |