CLASS II Drug recall · Reported 15 Jul 2015 · FDA Enforcement Report

Amlodipine besylate tablets, USP 2.5mg recalled

American Health Packaging is recalling Amlodipine besylate tablets, USP 2.5mg, distributed nationwide in the US. The recall was initiated on 1 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 131924, Exp 07/31/2015

Quantity recalled1,896 cartons

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-1218-2015
FDA event ID: 71553
Recalling firm: American Health Packaging, Columbus, OH
Classification: Class II
Status: Terminated
Recall initiated: 1 Jun 2015
FDA classified: 8 Jul 2015
Reported: 15 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Blood Pressure Medication

Timeline

1 Jun 2015	Recall initiated by company
8 Jul 2015	Classified by FDA	+37 days
15 Jul 2015	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

CGMP Deviations: Firm did not adequately investigate customer complaints.

Product as listed by the FDA

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 for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Firm did not adequately investigate customer complaints.

Which lots are affected?

Lot #: 131924, Exp 07/31/2015

Where was it sold?

Nationwide

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

12 other products · FDA event 71553

This product is part of a recall event; the main page for the event is Clarithromycin tablets, USP 500mg recalled by American Health Packaging.

Reported	Class	Recall	Company	Reason	Where
15 Jul 2015	CLASS II	Clarithromycin tablets, USP 500mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Zonisamide capsules, USP 100mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Azithromycin tablets, USP 500mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Lisinopril tablets, USP 5mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Lisinopril tablets, USP 40mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Azithromycin tablets, USP 250mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Amlodipine besylate tablets, USP 10 mg recalled	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Famotidine tablets, USP 20mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Lisinopril tablets, USP 20mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Amlodipine besylate tablets, USP 5mg recalled	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Lisinopril tablets, USP 10mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide
15 Jul 2015	CLASS II	Azithromycin tablets, USP 600mg recalled by American Health Packaging	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide

More recalls from American Health Packaging

All 60

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2 Feb 2022Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate	American Health Packaging	Potency & Assay	Nationwide

Other Amlodipine recalls

All 81

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
10 Jun 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
20 Aug 2025Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
6 Aug 2025Drug	CLASS II	Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalledAmlodipine Besylate And Benazepril Hydrochloride	Lupin Pharmaceuticals	Other	Nationwide
19 Jul 2023Drug	CLASS III	Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate	Lupin Pharmaceuticals	Potency & Assay	Nationwide