CLASS III Drug recall · Reported 26 Sep 2012 · FDA Enforcement Report

Enalapril Maleate Tablet, USP 5mg, Rx, Apace Packaging LLC recalled

Apace KY is recalling Enalapril Maleate Tablet, USP 5mg, Rx, Apace Packaging LLC, Ft. Run, KY 42133, distributed nationwide in the US. The recall was initiated on 4 Sep 2012 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot: DL11600 Exp Date: 06/13

Quantity recalled81,516 bottles

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-1683-2012
FDA event ID: 63080
Recalling firm: Apace KY, Fountain Run, KY
Classification: Class III
Status: Terminated
Recall initiated: 4 Sep 2012
FDA classified: 19 Sep 2012
Reported: 26 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Drug class: Blood Pressure Medication

Timeline

4 Sep 2012	Recall initiated by company
19 Sep 2012	Classified by FDA	+15 days
26 Sep 2012	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

Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

Which lots are affected?

Lot: DL11600 Exp Date: 06/13

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 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.

More recalls from Apace KY

All 5

Reported	Class	Recall	Company	Reason	Where
7 Mar 2018Drug	CLASS II	Acyclovir Tablets, USP, 400 mg dose blisters [ recalled by Apace KYAcyclovir	Apace KY	Other	Nationwide
9 Aug 2017Drug	CLASS II	Cyclobenzaprine HCl Tablets, USP, 5 mg Unit Dose recalled by Apace KY	Apace KY	Other	KY
9 Aug 2017Drug	CLASS II	Amantadine HCl Capsules, USP, 100 mg recalled by Apace KY	Apace KY	Other	KY
13 Apr 2016Drug	CLASS III	Minocycline Hydrochloride Capsules USP, 100 mg* Dose blisters recalled	Apace KY	Labeling Errors	Nationwide

Other Enalapril recalls

All 21

Reported	Class	Recall	Company	Reason	Where
13 May 2026Drug	CLASS II	Enalapril Maleate Tablets, USP, 20 mg recalled by JB Chemicals andEnalapril Maleate	JB Chemicals and Pharmaceuticals	Potency & Assay	Nationwide
13 Jul 2022Drug	CLASS II	Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate	Golden State Medical Supply	Manufacturing (CGMP) Deviations	Nationwide
13 Jul 2022Drug	CLASS II	Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate	Golden State Medical Supply	Manufacturing (CGMP) Deviations	Nationwide
13 Jul 2022Drug	CLASS II	Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate	Golden State Medical Supply	Manufacturing (CGMP) Deviations	Nationwide
13 Jul 2022Drug	CLASS II	Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate	Golden State Medical Supply	Manufacturing (CGMP) Deviations	Nationwide