Synergy Rx Recalls Betamethasone 0.25% Due to Sterility Assurance Issues
Synergy Rx is recalling Betamethasone 0.25% cream because it may not be sterile. The recall covers all lots distributed nationwide.
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 agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in a prescription drug, which poses a significant risk of infection or injury, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Synergy Rx is recalling Betamethasone 0.25%, a prescription-only medication, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations. The product is distributed nationwide within the United States.
The recall applies to all lots of the product. The source text does not specify a particular date range or quantity of units affected.
Consumers should stop using the product and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
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.
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