CLASS II Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report

Cephalexin Monohydrate Capsules,USP, 500 mg recalled

Physicians Total Care is recalling Cephalexin Monohydrate Capsules,USP, 500 mg, distributed in Georgia, Missouri. The recall was initiated on 22 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)

Quantity recalled340 capsules (17 bottles containing 20 capsules each)

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-0237-2015
FDA event ID: 69597
Recalling firm: Physicians Total Care, Tulsa, OK
Classification: Class II
Status: Terminated
Recall initiated: 22 Sep 2014
FDA classified: 5 Nov 2014
Reported: 12 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Antibiotics

Timeline

22 Sep 2014	Recall initiated by company
5 Nov 2014	Classified by FDA	+44 days
12 Nov 2014	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: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.

Product as listed by the FDA

CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233

Where it was distributed

Distributed in Georgia and Missouri.

Georgia Missouri

Questions about this recall

Is Cephalexin Monohydrate Capsules,USP, 500 mg recalled?

Yes. Physicians Total Care recalled Cephalexin Monohydrate Capsules,USP, 500 mg on 22 Sep 2014. The recall is Class II and its status is Terminated. Recall number D-0237-2015.

Why was it recalled?

CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.

Which lots are affected?

Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)

Where was it sold?

Distributed in Georgia and Missouri.

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.

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