Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1218-2015·Announced 2015-07-15

Amlodipine besylate tablets recalled for inadequate complaint investigation

American Health Packaging is recalling 1,896 cartons of Amlodipine besylate tablets 2.5mg due to inadequate investigation of customer complaints.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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 and involves a CGMP deviation (inadequate complaint investigation) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

American Health Packaging is recalling 1,896 cartons of Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters. The product is distributed nationwide and is identified by Lot # 131924 with an expiration date of 07/31/2015. The tablets are manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt, USA, LLC in Parsippany, NJ.

The recall was initiated because the firm did not adequately investigate customer complaints, which constitutes a deviation from Current Good Manufacturing Practices (CGMP). The source text does not report any specific illnesses, injuries, or deaths associated with this product.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II.

The recalled product

Product: Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA…
Manufacturer: American Health Packaging
Category: Drug — Prescription Medication
Hazard: cgmp-deviation
inadequate-investigation
Affected units: 1,896

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 #: 131924
Exp 07/31/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by American Health Packaging 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 13 products in this recall →

Same manufacturer · American Health Packaging

See all →

Low
Buprenorphine Sublingual Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-09-09
Moderate
Nitrofurantoin Capsules 100 mg recalled for failed dissolution specifications
FDA (Drugs) · 2022-05-25
Moderate
Cyanocobalamin Injection Recalled Due to Subpotency and Assay Non-Compliance
FDA (Drugs) · 2022-05-04
Severe
Oxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
Moderate
Metoprolol Succinate ER Tablets Recall for Failed Dissolution
FDA (Drugs) · 2022-02-02

Same hazard · cgmp deviation