RecallRadar

FDA Drug recall D-0237-2015

CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Ph…

On 2014-11-12 the FDA classified a Class II recall of CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Ph… by Physicians Total Care, citing CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0237-2015
ClassificationClass II
Statusterminated
Initiated2014-09-22
Published2014-11-12
Last updated2026-09-13 11:51 UTC
CompanyPhysicians Total Care
DistributionGA, MO

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0237-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.