CLASS III Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report

Nifedipine Extended-Release Tablets, 60 mg recalled by Alvogen

Alvogen is recalling Nifedipine Extended-Release Tablets, 60 mg, distributed nationwide in the US. The recall was initiated on 7 Mar 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.

Quantity recalledN/A

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-0630-2017
FDA event ID: 76664
Recalling firm: Alvogen, Pine Brook, NJ
Classification: Class III
Status: Terminated
Recall initiated: 7 Mar 2017
FDA classified: 4 Apr 2017
Reported: 12 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Blood Pressure Medication

Timeline

7 Mar 2017	Recall initiated by company
4 Apr 2017	Classified by FDA	+28 days
12 Apr 2017	Published in enforcement report	+8 days

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

Reason for recall

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Product as listed by the FDA

Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.

Where it was distributed

Nationwide

Questions about this recall

Is Nifedipine Extended-Release Tablets, 60 mg recalled?

Yes. Alvogen recalled Nifedipine Extended-Release Tablets, 60 mg on 7 Mar 2017. The recall is Class III and its status is Terminated. Recall number D-0630-2017.

Why was it recalled?

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Which lots are affected?

Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

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Other Nifedipine recalls

All 9

Reported	Class	Recall	Company	Reason	Where
21 Jul 2021Drug	CLASS II	NIFEdipine Extended-release Tablets, USP 30 mg recalledNifedipine	The Harvard Drug Group	Potency & Assay	NJ, OH
28 Feb 2018Drug	CLASS II	Nifedipine USP for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
12 Apr 2017Drug	CLASS III	Nifedipine Extended-Release Tablets, 30 mg recalled by Alvogen	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Nifedipine Extended-Release Tablets, 90 mg recalled by Alvogen	Alvogen	Other	Nationwide
30 Nov 2016Drug	CLASS III	NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth	Actavis Elizabeth	Other	NJ