Recall: Isomeric Betamethasone Injectable Suspension Due to Drug Clumps
Isomeric Pharmacy Solution recalls specific lots of Betamethasone Acetate/Sodium Phosphate injectable suspension due to potential drug clumps and larger particle sizes.
Stop using this now
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
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What happened, in plain English
Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension (7 mg/mL) in 10 mL multi-dose vials. The recall is due to a lack of processing controls that may result in drug clumps and larger particle sizes within the sterile product. This affects specific lots distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/42506-recall-isomeric-betamethasone-injectable-suspension-due-to-drug-clumps.
Source Summary by GovInfoNow · govinfonow.com/recall/42506-recall-isomeric-betamethasone-injectable-suspension-due-to-drug-clumps · Updated October 11, 2026 · FDA enforcement record: FDA #D-1454-2016
Cite this page
“Recall: Isomeric Betamethasone Injectable Suspension Due to Drug Clumps.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42506-recall-isomeric-betamethasone-injectable-suspension-due-to-drug-clumps. Based on FDA recall #D-1454-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1454-2016%22&limit=1).
Why it’s dangerous
The lack of processing controls can lead to the formation of drug clumps and larger particle sizes in the sterile injectable suspension. Ingesting or injecting these particles could compromise the safety and efficacy of the medication, posing a health risk to the patient.
Who’s affected
Patients prescribed this Rx-only injectable suspension by healthcare providers. Individuals who have received or possess vials from the specific lot numbers listed below are at risk of using a product with potential particulate contamination.
How to tell if you have this one
Check your vials for the following details: Brand: Isomeric Pharmacy Solution; Product: Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/mL, 10 mL Multi-Dose vial. Affected Lot Numbers and Expiration Dates: Lot 03037 (Exp 8/17/16); Lots 03042, 03043 (Exp 8/31/16); Lot 04043 (Exp 9/29/16); Lots 04047, 04048 (Exp 10/1/16); Lots 04052, 04053 (Exp 10/2/16); Lot 05042 (Exp 10/29/16); Lot 05046 (Exp 11/2/16); Lots 05048, 05049 (Exp 11/3/16); Lot 05050 (Exp 11/4/16).
- Brand
Isomeric Pharmacy Solution- Category
Drug
What to do — step by step
Stop using the product
Do not use any vials matching the recalled lot numbers and expiration dates listed in the record.
Contact your healthcare provider
Reach out to the prescribing doctor or pharmacist immediately to discuss alternative treatment options and proper disposal of the recalled medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1454-2016 (August 1, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1454-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.