CLASS II Drug recall · Reported 22 Jan 2014 · FDA Enforcement Report

Cinacalcet HCL Tablet, 60 mg recalled by Aidapak Services

Aidapak Services is recalling Cinacalcet HCL Tablet, 60 mg, distributed in Arizona, California, Oregon, Washington. The recall was initiated on 2 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCINACALCET HCL, Tablet, 60 mg has the following code Pedigree: W003742, EXP: 6/26/2014.

Quantity recalled60 Tablets

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-625-2014
FDA event ID: 65707
Recalling firm: Aidapak Services, Vancouver, WA
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2013
FDA classified: 16 Jan 2014
Reported: 22 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Labeling Errors

Timeline

2 Jul 2013	Recall initiated by company
16 Jan 2014	Classified by FDA	+198 days
22 Jan 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling:Label Mixup; CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003741, EXP: 6/26/2014.

Product as listed by the FDA

CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007430

Where it was distributed

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Arizona California Oregon Washington

Questions about this recall

Is Cinacalcet HCL Tablet, 60 mg recalled?

Yes. Aidapak Services recalled Cinacalcet HCL Tablet, 60 mg on 2 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-625-2014.

Why was it recalled?

Labeling:Label Mixup; CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003741, EXP: 6/26/2014.

Which lots are affected?

CINACALCET HCL, Tablet, 60 mg has the following code Pedigree: W003742, EXP: 6/26/2014.

Where was it sold?

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Aidapak Services

All 538

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29 Jan 2014Drug	CLASS II	MERCapsuleTOPURINE, Tablet, 50 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
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8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
1 Jul 2026Drug	CLASS II	Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar	Amgen	Manufacturing (CGMP) Deviations	Nationwide
1 Jul 2026Drug	CLASS II	Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar	Amgen	Manufacturing (CGMP) Deviations	Nationwide