Strides Pharma Benzonatate Capsules Recall: Methylparaben Stability Issue
Strides Pharma recalls 200mg Benzonatate capsules with failed stability tests for Methylparaben. Rx-only capsules from specific lots may have unsafe preservative levels.
Lower-risk recall
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
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What happened, in plain English
Strides Pharma is recalling 200mg Benzonatate capsules that failed stability tests for the preservative Methylparaben. This could mean the capsules have unsafe preservative levels that might affect safety when taken as directed. Read more at govinfonow.com/recall/41629-strides-pharma-benzonatate-capsules-recall-methylparaben-stability-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/41629-strides-pharma-benzonatate-capsules-recall-methylparaben-stability-issue · Updated October 8, 2026 · FDA enforcement record: FDA #D-0858-2017
Cite this page
“Strides Pharma Benzonatate Capsules Recall: Methylparaben Stability Issue.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41629-strides-pharma-benzonatate-capsules-recall-methylparaben-stability-issue. Based on FDA recall #D-0858-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0858-2017%22&limit=1).
Why it’s dangerous
The capsules failed stability tests for Methylparaben content, which is a preservative. This could mean the preservative levels are too high or too low, potentially affecting the safety of the medication when taken.
Who’s affected
Prescription owners of Benzonatate capsules with specific lot numbers from the recall list. People taking these capsules for cough relief are most at risk.
How to tell if you have this one
Check for Benzonatate capsules labeled 200mg, 100-count, prescription-only. Look for lot numbers 7225075-7225080 (exp 7/2017), 7225180-7225181, 7225322-7225323 (exp 8/2017), or 7225649A-7225654A (exp 9/2017).
- Brand
Strides Pharma- Category
Drug
What to do — step by step
Check Capsule Lot Number
Look for the lot number on the bottle to see if it matches the recalled lots listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 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-0858-2017 (May 9, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0858-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.