Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Capsules
Zydus Pharmaceuticals is recalling 58,920 bottles of Benzonatate Capsules, 200 mg, because some capsules are wet or leaking.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a physical defect (wet/leaking capsules) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor defects or low-risk issues.
Plain-English summary
Zydus Pharmaceuticals USA Inc is recalling 58,920 bottles of Benzonatate Capsules, USP, 200 mg, 100-count bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico.
The recall was initiated because some capsules failed specifications by being wet and/or leaking. The affected lots are MP2137, MP2138, and MP2139 (Exp 01/16); MP3614 (Exp 03/16); and MP5611 and MP5613 (Exp 05/16). The product was manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc in Pennington, NJ.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Affected units
- 58,920
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 (9)
- Lot #: MP2137
- MP2138
- MP2139
- Exp 01/16
- MP3614
- Exp 03/16
- MP5611
- MP5613
- Exp 05/16
Distribution
Related recalls
Same manufacturer · Zydus Pharmaceuticals USA Inc
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- HighIcosapent ethyl capsules recalled after active ingredient oxidized inside capsule
FDA (Drugs) · 2026-03-18
- HighIcosapent ethyl capsules recalled as subpotent after capsule contents leaked
FDA (Drugs) · 2026-01-28
Same hazard · physical defect
See all →- HighThermodilution Catheter May Bend During Use, Causing Monitor Errors
FDA (Devices) · 2023-04-19
- ModerateBard Clean-Cath Intermittent Catheter Recalled for Packaging and Tip Defects
FDA (Devices) · 2021-04-28
- HighFerring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System
FDA (Drugs) · 2021-04-07
- HighROi CPS Recalls Custom Procedure Packs with Flaking Gauze Sponges
FDA (Devices) · 2021-01-06
- HighGE Healthcare Recalls Flow Sensor Service Parts with Damaged Tubes
FDA (Devices) · 2020-11-11