Synergy Rx Recalls Erythromycin Cream Due to Sterility Assurance Issues
Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05% due to lack of assurance of sterility and CGMP deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05%, prescription-only products, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations.
The affected products were distributed nationwide within the United States. The recall covers all lots of the specified products.
Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on alternative treatments or disposal.
The recalled product
- Product
- ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 81 recalled by Synergy Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 81 products in this recall →Related recalls
Same manufacturer · Synergy Rx
See all →- SevereSynergy Rx Recalls Lidocaine Creams Due to Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
- HighSynergy Rx Recalls Ultra Lite Cream Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- SevereSynergy Rx Recalls Lactic Acid Solution Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- HighSynergy Rx Modified Jessner Peel Recalled for Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
- SevereSynergy Rx Recalls CLEAR 2 Due to Sterility Assurance Concerns
FDA (Drugs) · 2017-03-22
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereEPINEPHrine Injection Recall Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-01-05
- HighHydromorphone Syringe Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- SevereEpinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-01-05
- SevereSterRx Epinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-01-05
- ModerateErythromycin Topical Gel 2% Recalled Due to Failed Impurity Specifications
FDA (Drugs) · 2021-07-28
- HighFDA Recalls HYDROmorphone Syringes for Sterility Assurance Issue
FDA (Drugs) · 2023-10-11