Class III · Low risk
Benzonatate Capsules
Superpotent drug: Assay results were slightly above specification at the time zero point.
Benzonatate capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What 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
Affected NDC
64380-0713-06
Compare with the code on your package — it is the most precise check available.
Drug: Benzonatate
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Benzonatate NDC 64380-0713 |
200 mg/1 | Capsule Oral |
Strides Pharma Science Limited | Rx |
- Recalling firm
- Strides Pharma INC
- NDC code
- 64380-713-06
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0858-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Benzonatate recalls
See all
Class I · High risk
Benzonatate capsules
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Other recalls by Strides Pharma INC
All 2017 recalls
Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Class II · Moderate risk
Cinacalcet Tablets 90 mg
Failed Dissolution Specifications.
Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk
Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
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