Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported May 31, 2017
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Strides Pharma INC recalled Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun … - a low-severity action.
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun … was recalled by Strides Pharma INC in May 31, 2017. Reason: Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.. Check the official notice for the remedy. Verify recall #D-0858-2017 with the FDA Drug before acting.
The recall
Strides Pharma INC issued this low-severity FDA Drug recall-Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content..
- Low
- severity level
- Class III
- classification
- May 31, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0858-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0858-2017) was formally reported on May 31, 2017, with the manufacturer initiating the action on May 9, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Strides Pharma INC is listed as the recalling firm, operating out of East Brunswick, NJ. Federal records list the affected scope as 127,517 bottles.
The documented reason for this recall is: Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content. Distribution data in the federal record shows the product reached: U.S.A. Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
127,517 bottles
Related Recalls
6
0 from same agency
Product description
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
Reason for recall
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0858-2017 |
| Date reported | May 31, 2017 |
| Date initiated | May 9, 2017 |
| Recalling firm | Strides Pharma INC |
| Firm location | East Brunswick, NJ |
| Affected scope | 127,517 bottles |
| Distribution | U.S.A. Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0858-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06. Recalled by Strides Pharma INC. Units affected: 127,517 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2017. Severity: Low. Recall number: D-0858-2017.
Where was the recalled product distributed? ▼
Distribution: U.S.A. Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0858-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 31, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.