Zydus Recalls Amlodipine Besylate Tablets Due to Discoloration
Zydus Pharmaceuticals is recalling Amlodipine Besylate 10 mg tablets due to brown spots embedded in the product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is cosmetic discoloration (brown spots) with no reported illnesses or injuries.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling Amlodipine Besylate Tablets, USP 10 mg, Lot # MP4344. The recall was initiated because brown spots were noted embedded in the tablets.
The affected product is distributed nationwide. The specific lot number is MP4344, with an expiration date of 04/2016. The product is manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ.
Consumers should check their medication for the specific lot number and expiration date. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 15,144
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 (2)
- Lot #: MP4344
- Exp 04/2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · AMLODIPINE BESYLATE
- ModerateAmlodipine Besylate 10 mg Tablets Recalled for Failing Potency Tests
FDA (Drugs) · 2023-07-19
- ModerateInvaGen Recalls Amlodipine Besylate Tablets Due to Subpotency
FDA (Drugs) · 2018-10-17
- ModerateAscend Amlodipine Besylate Tablets Recalled for Foreign Tablet Presence
FDA (Drugs) · 2017-09-20
- ModerateLupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
FDA (Drugs) · 2016-09-14
- LowLupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
FDA (Drugs) · 2016-09-14
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 · discoloration
See all →- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- ModeratePantoprazole Sodium Tablets Recalled for Discoloration Issues
FDA (Drugs) · 2026-04-29
- ModerateTavaborole topical solution recalled from three lots because of discoloration
FDA (Drugs) · 2025-10-22
- ModerateAcetaminophen injection containers recalled after discoloration found in one lot
FDA (Drugs) · 2025-09-03