Ranier's Compounding Laboratory Recalls Atropine 0.01% Opth Solution
Ranier's Compounding Laboratory is recalling Atropine 0.01% Opth Solution due to a lack of assurance of sterility. The product was distributed within Pennsylvania.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure for a sterile product, align with the Severe classification criteria.
Plain-English summary
Ranier's Compounding Laboratory is recalling Atropine 0.01% Opth Solution, 5 mL droptainer, prescription only. The recall is being conducted because practices at the firm may call into question the sterility of products intended to be sterile.
The affected product was distributed within the state of Pennsylvania. The recall covers all lots within expiry.
Consumers should stop using the product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
- Manufacturer
- Ranier's Compounding Laboratory
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 5
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 within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 15 recalled by Ranier's Compounding Laboratory 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 15 products in this recall →Related recalls
Same manufacturer · Ranier's Compounding Laboratory
See all →- SevereRanier's Compounding Laboratory Recalls Acetylcysteine 10% Ophthalmic Solution
FDA (Drugs) · 2018-08-22
- SevereRanier's Compounding Laboratory Recalls DMSO 6.25% Opth Sol for Sterility Concerns
FDA (Drugs) · 2018-08-22
- SevereRanier's Compounding Laboratory Recalls Vitamin D3 Injection Due to Sterility Concerns
FDA (Drugs) · 2018-08-22
- SevereRanier's Triple P Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2018-08-22
- SevereRanier's PR/PA/PH Injection Recalled for Sterility Concerns
FDA (Drugs) · 2018-08-22
Same hazard · sterility failure
See all →- 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
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22