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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86285

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

Open FDA event record

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

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.