Exact FDA event identifier

Event 86285

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 24, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Teva Pharmaceuticals USA

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

D-0012-2021

Recall number: D-0012-2021
Initiated: August 24, 2020
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA
Quantity: 103,940 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Code information

Lot #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021.

Distribution pattern

Nationwide in the U.S. and Puerto Rico.

drug · product 2 of 3

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

D-0013-2021

Recall number: D-0013-2021
Initiated: August 24, 2020
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA
Quantity: 1,467,535 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Code information

Lot #s: a) 30309862A, 30309863A, Exp. 08/2020; 30309928A, 30309929A, Exp. 09/2020; 30310029A, 30310030A, 30310033A, 30310034A, Exp. 10/2020; 30310035A, 30310079A, 30310080A, 30310081A, Exp. 11/2020; 30310134A, 30310135A, Exp. 01/2021; 30310182A, 30310183A, 30310210A, Exp. 02/2021; 30310211A, 30310246A, Exp. 03/2021; 30310282A, Exp. 04/2021; 30310290A, Exp. 05/2021; 30310394A, 30310395A, Exp.07/2021; 30310457A, Exp. 09/2021; 30310506A, 30310507A, Exp. 10/2021; 30310555A, 30310605A, Exp. 11/2021. b) 30309864A, 30309865A, Exp. 08/2020; 30309930A, 30309931A, Exp. 09/2020; 30309991A, 30309992A, 30310028A, Exp.10/2020; 30310036A, 30310037A, 30310038A, Exp. 11/2020; 30310082A, 30310083A, Exp. 12/2020; 30310136A, 30310137A, Exp. 01/2021; 30310184A, 30310185A, Exp. 02/2021; 30310212A, Exp. 03/2021; 30310303A, Exp. 04/2021; 30310327A, Exp. 06/2021; 30310396A, 30310407A, Exp. 08/2021; 30310445A, Exp. 09/2021; 30310556A, Exp. 10/2021.

Distribution pattern

Nationwide in the U.S. and Puerto Rico.

drug · product 3 of 3

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.

D-1566-2020

Recall number: D-1566-2020
Initiated: August 24, 2020
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA
Quantity: 38,487 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 30310638A, Exp. 02/2022

Distribution pattern

Nationwide in the U.S. and Puerto Rico.