Strides Pharma Recalls Benzonatate Capsules for Stability Failure
Strides Pharma Inc. is recalling Benzonatate capsules due to out-of-specification preservative levels. The FDA classified this as a Class III recall.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Strides Pharma Inc. is recalling Benzonatate capsules, 200 mg, 100-count bottles, due to failed stability specifications. The recall involves out-of-specification results for the preservative Methylparaben content. The affected product is a prescription-only medication manufactured by Strides Shasun Limited in India and distributed by Strides Pharma Inc. in East Brunswick, New Jersey.
The recall covers 127,517 bottles distributed nationwide in the United States. Specific lot numbers and expiration dates are listed in the official recall notice. The FDA has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected Benzonatate capsules and return them to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- BENZONATATE (BENZONATATE)
- Brand
- BENZONATATE
- Manufacturer
- Strides Pharma INC
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 127,517
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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
UPCs (4)
- 0364380713074
- 0364380712060
- 0364380712077
- 0364380713067
Distribution
Distributed nationwide across the United States.
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