RecallRadar

FDA Drug recall D-1566-2020

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmac…

On 2020-09-16 the FDA classified a Class II recall of Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmac… by Teva Pharmaceuticals Usa, citing sub-Potent Drug: Out of specification test results for potency (below specification).

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1566-2020
ClassificationClass II
Statusterminated
Initiated2020-08-24
Published2020-09-16
Last updated2026-09-13 11:52 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

Product

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.

Reason

Sub-Potent Drug: Out of specification test results for potency (below specification).

Identifiers

ndc0093-3145-01
ndc0093-3145-05
ndc0093-3147-01
ndc0093-3147-05
ndc0093-4175-73
ndc0093-4175-74
ndc0093-4177-73
ndc0093-4177-74
code_infoLot #: 30310638A, Exp. 02/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1566-2020%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.