CLASS III Drug recall · Reported 31 May 2017 · FDA Enforcement Report

Benzonatate capsules, 200 mg recalled by Strides Pharma

Strides Pharma is recalling Benzonatate capsules, 200 mg, distributed nationwide in the US. The recall was initiated on 9 May 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 7225075, 7225076, 7225077, 7225078, 7225079, 7225080 Exp 7/2017; 7225180, 7225181, 7225322, 7225323, Exp 8/2017; 7225649A, 7225650A , 7225651A , 7225652A, 7225653A, 7225654A, Exp 9/2017

NDC64380-712, 64380-713

UPC0364380713074, 0364380712060, 0364380712077, 0364380713067

Quantity recalled127,517 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0858-2017
FDA event ID: 77311
Recalling firm: Strides Pharma, East Brunswick, NJ
Brand: Benzonatate
Manufacturer: Strides Pharma Science Limited
Classification: Class III
Status: Terminated
Recall initiated: 9 May 2017
FDA classified: 23 May 2017
Reported: 31 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

9 May 2017	Recall initiated by company
23 May 2017	Classified by FDA	+14 days
31 May 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

U.S.A. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.

Which lots are affected?

Lot #: 7225075, 7225076, 7225077, 7225078, 7225079, 7225080 Exp 7/2017; 7225180, 7225181, 7225322, 7225323, Exp 8/2017; 7225649A, 7225650A , 7225651A , 7225652A, 7225653A, 7225654A, Exp 9/2017

Where was it sold?

U.S.A. Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Strides Pharma

All 13

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen	Strides Pharma	Particulate Matter	Nationwide
6 Aug 2025Drug	CLASS II	Cinacalcet Tablets 90 mg recalled by Strides PharmaCinacalcet	Strides Pharma	Potency & Assay	Nationwide
2 Apr 2025Drug	CLASS II	Testosterone Gel 1%-dose packets recalled by Strides PharmaTestosterone	Strides Pharma	Benzene	Nationwide
2 Apr 2025Drug	CLASS II	Testosterone Gel 1%-dose Packets recalled by Strides PharmaTestosterone	Strides Pharma	Benzene	Nationwide
31 Jan 2024Drug	CLASS II	Methoxsalen Capsules, USP 10mg recalled by Strides PharmaMethoxsalen	Strides Pharma	Potency & Assay	Nationwide

Other Benzonatate recalls

All 7

Reported	Class	Recall	Company	Reason	Where
31 Jan 2024Drug	CLASS III	Benzonatate Capsules, USP, 100 mg x dose cards) recalledBenzonatate	Amerisource Health Services	Potency & Assay	Nationwide
1 Jun 2022Drug	CLASS I	Benzonatate capsules, 100mg recalled by Calvin Scott & Company	Calvin Scott	Packaging Defects	GA
8 Apr 2015Drug	CLASS II	Benzonatate Capsules, USP, 100 mg recalled by American Health PackagingBenzonatate	American Health Packaging	Packaging Defects	Nationwide
31 Dec 2014Drug	CLASS II	Benzonatate Capsules, USP, 100 mg recalled by Zydus Pharmaceuticals USABenzonatate	Zydus Pharmaceuticals USA	Packaging Defects	Nationwide
24 Dec 2014Drug	CLASS II	Benzonatate Capsules, USP, 200 mg recalled by Zydus Pharmaceuticals USA	Zydus Pharmaceuticals USA	Packaging Defects	Nationwide