CLASS III Drug recall · Reported 10 Dec 2014 · FDA Enforcement Report
Benzonatate Capsules, USP, 200 mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Benzonatate Capsules, USP, 200 mg, distributed nationwide in the US. The recall was initiated on 24 Sep 2014 and the FDA has classified it as Class III.
Check your package
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-0289-2015
- FDA event ID
- 69585
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Sep 2014
- FDA classified
- 3 Dec 2014
- Reported
- 10 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 24 Sep 2014 | Recall initiated by company | |
| 3 Dec 2014 | Classified by FDA | +70 days |
| 10 Dec 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Product as listed by the FDA
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
Where it was distributed
US Nationwide including Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Which lots are affected?
Lot #: MM8555, Expiry: 09/14; Lot #: MM6604, Expiry: 09/14; Lot #: MM8551, Expiry: 09/14; Lot #: MM8552, Expiry: 09/14; Lot #: MM8553, Expiry: 09/14; Lot #: MM8554, Expiry: 09/14.
Where was it sold?
US Nationwide including Puerto Rico
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 Zydus Pharmaceuticals USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
Other Benzonatate recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Benzonatate Capsules, USP, 100 mg x dose cards) recalledBenzonatate | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS I | Benzonatate capsules, 100mg recalled by Calvin Scott & Company | Calvin Scott | Packaging Defects | GA |
| Drug | CLASS III | Benzonatate capsules, 200 mg recalled by Strides PharmaBenzonatate | Strides Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Benzonatate Capsules, USP, 100 mg recalled by American Health PackagingBenzonatate | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Benzonatate Capsules, USP, 100 mg recalled by Zydus Pharmaceuticals USABenzonatate | Zydus Pharmaceuticals USA | Packaging Defects | Nationwide |