Abrams Royal Pharmacy Recalls All Unexpired Sterile Drug Products
Abrams Royal Pharmacy is recalling all unexpired sterile drug products due to a lack of assurance of sterility. The products were distributed nationwide and to Canada.
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the provided text, the classification of Class II for sterile products implies a significant risk of harm, fitting the Severe criteria better than High (3) which is typically for theoretical risks or specific pathogens without reported illness.
Plain-English summary
Abrams Royal Pharmacy Inc. of Dallas, Texas, is recalling all unexpired sterile drug products compounded by the facility. The recall was initiated because of a lack of assurance of sterility in the products.
The affected products were distributed nationwide and to Canada. The recall covers all unexpired lots of sterile drug products.
Consumers should stop using these products and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
- Manufacturer
- Abrams Royal Pharamacy
- Category
- Drug — Sterile Compounded Drugs
- 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 unexpired lots of sterile drug products
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Abrams Royal Pharamacy 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 2 products in this recall →Related recalls
Same manufacturer · Abrams Royal Pharamacy
See all →- CriticalAbrams Royal Pharmacy Recalls Non-Sterile Mineral IV Injection
FDA (Drugs) · 2014-09-03
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
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- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
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- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
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