Blu Pharmaceuticals Recalls Simvastatin 5mg Due to Subpotency
Blu Pharmaceuticals recalls specific lots of Simvastatin Tablets USP 5 mg because they may be subpotent. Check your bottle's NDC and lot number for details.
Use caution until it’s fixed
Subpotent Drug
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What happened, in plain English
Biocon Inc, manufacturing for Blu Pharmaceuticals, is recalling Simvastatin Tablets, USP 5 mg in 90-count and 1000-count bottles. The recalled product is classified as a Class III recall due to being a subpotent drug, meaning it may not contain the full amount of active ingredient. The record does not specify a remedy or action for consumers. Read more at govinfonow.com/recall/43099-blu-pharmaceuticals-recalls-simvastatin-5mg-due-to-subpotency.
Source Summary by GovInfoNow · govinfonow.com/recall/43099-blu-pharmaceuticals-recalls-simvastatin-5mg-due-to-subpotency · Updated October 11, 2026 · FDA enforcement record: FDA #D-0817-2016
Cite this page
“Blu Pharmaceuticals Recalls Simvastatin 5mg Due to Subpotency.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43099-blu-pharmaceuticals-recalls-simvastatin-5mg-due-to-subpotency. Based on FDA recall #D-0817-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0817-2016%22&limit=1).
Why it’s dangerous
The drug is described as 'subpotent,' which means it may contain less than the labeled amount of active ingredient. This could result in the medication being less effective for treating high cholesterol or preventing cardiovascular events, potentially leading to inadequate treatment of the condition.
Who’s affected
Patients in Pennsylvania, California, and Ohio who were prescribed Simvastatin Tablets USP 5 mg by Blu Pharmaceuticals. Individuals with this specific prescription are at risk of receiving medication that may not work as intended.
How to tell if you have this one
Look for Simvastatin Tablets, USP 5 mg bottles manufactured by Blu Caribe (Dorado PR) for Blu Pharmaceuticals (Franklin, KY). Check for NDC 24658-0300-90 (90 count) or NDC 24658-0300-10 (1000 count), Lot # 14S0042F5B, with an expiration date of 4/2016.
- Brand
Blu Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Simvastatin bottles match the NDC numbers and lot number listed in the recall details.
Consult Your Pharmacist
Contact your pharmacist or healthcare provider to determine if you have the recalled product and what steps to take next.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “PA, CA, & OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Ohio, Pennsylvania.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0817-2016 (March 24, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0817-2016 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.