Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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 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
Lupin Limited is recalling Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles. The recall involves 43,536 bottles of the prescription medication, identified by Lot # G304799 and an expiration date of 4/2016. The product was manufactured in India for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and distributed only within the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the finished products were manufactured using active pharmaceutical ingredients whose intermediates failed specifications. This indicates a potential quality control issue during the manufacturing process.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement. The recall is classified as Class III by the FDA, which indicates that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- Lupin Limited
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 43,536
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 #: G304799
- Exp. 4/2016
UPCs (1)
- 0368180233022
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Lupin Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →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
- LowZydus Recalls Amlodipine Besylate Tablets Due to Discoloration
FDA (Drugs) · 2014-12-03
Same manufacturer · Lupin Limited
See all →- ModerateLupin Recalls Pravastatin Sodium Tablets Due to Foreign Capsule Presence
FDA (Drugs) · 2017-11-29
- LowLupin Recalls Escitalopram Tablets Due to Incorrect or Missing Lot and Expiration Dates
FDA (Drugs) · 2016-09-28
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- SevereShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19