CLASS III Drug recall · Reported 8 Mar 2017 · FDA Enforcement Report
Salicylic Acid Cream recalled by L. Perrigo
L. Perrigo is recalling Salicylic Acid Cream, 6%, distributed nationwide in the US. The recall was initiated on 13 Feb 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-0504-2017
- FDA event ID
- 76443
- Recalling firm
- L. Perrigo, Allegan, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Feb 2017
- FDA classified
- 1 Mar 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 13 Feb 2017 | Recall initiated by company | |
| 1 Mar 2017 | Classified by FDA | +16 days |
| 8 Mar 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
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
Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.
Where it was distributed
Nationwide within United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Which lots are affected?
Lot #: 098840, 098779, Exp.06/18.
Where was it sold?
Nationwide within 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 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 76443| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Salicylic Acid Shampoo recalled by L. Perrigo | L. Perrigo | Potency & Assay | Nationwide |
More recalls from L. Perrigo
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg recalledExchange Select Aller Ease | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy Aller-fex, Fexofenadine Hydrochloride Tablets, 180 mg recalledKirkland Signature Aller Fex | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride recalledBerkley Jensen Allergy Relief | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Allergy, Fexofenadine Hydrochloride Tablets, 180 mg recalledBasic Care Allergy | L. Perrigo | Potency & Assay | Nationwide |
| Drug | CLASS II | Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine recalled | L. Perrigo | Potency & Assay | Nationwide |
Other Salicylic Acid recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kingskin, Elimina Las Verrugas, For the removal of common warts fl recalledKingskin | Pharmadel | Manufacturing (CGMP) Deviations | DE |
| Drug | CLASS III | Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%) recalledClearasil Rapid Rescue Deep Treatment Pads | RB Health | Labeling Errors | Nationwide |
| Drug | CLASS II | Salicylic Acid Solution in all strengths including recalled | Synergy Rx | Sterility | Nationwide |