Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85224

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

Open FDA event record

Event summary

Timeline bucket
March 16, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Glaxosmithkline Consumer Healthcare Holdings

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

5 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 5

Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister

D-1065-2020
Recall number
D-1065-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
471,024 blisters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Code information

Batch/Lot Numbers: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021

Distribution pattern

Product was distributed throughout the United States, including Puerto Rico.

drug · product 2 of 5

Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95

D-1066-2020
Recall number
D-1066-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
446,628 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Code information

Batch/Lot Numbers: R53074, exp. date 10/31/2020, item # F00573176989, 160 ct. R53075, exp. date 10/31/2020, item # F00573176989, 160 ct. R53076, exp. date 11/30/2020, item # F00573176989, 160 ct. R53077, exp. date 11/30/2020, item # F00573176989, 160 ct. R53081, exp. date 11/30/2020, item # F00573176989, 160 ct. R53901, exp. date 02/28/2021, item # F00573176989, 160 ct. R53902, exp. date 03/31/2021, item # F00573176989, 160 ct. R62780, exp. date 06/30/2021, item # F00573176989, 160 ct.

Distribution pattern

Product was distributed throughout the United States, including Puerto Rico.

drug · product 3 of 5

Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

D-1067-2020
Recall number
D-1067-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
151,056 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Code information

Batch/Lot # R73761, exp. date 01/31/2021, Item # F00573019175, 0.75 oz. R74936, exp. date 02/28/2021, Item # F00573019175, 0.75 oz. R56290, exp. date 03/31/2020, Item # F00573019150, 1 oz. R60959, exp. date 02/28/2021, Item # F00573019150, 1 oz. R78826, exp. date 11/30/2021, Item # F00573019150, 1 oz. 9335UA, exp. date 01/31/2021, item # F00573019175A - Co-package 9336UA, exp. date 02/28/2021, item # F00573019175A - Co-package

Distribution pattern

Product was distributed throughout the United States, including Puerto Rico.

drug · product 4 of 5

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA

D-1068-2020
Recall number
D-1068-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
566 blister packs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Code information

Batch/Lot # 0045DB, exp. date 07/31/2021, original lot # R73995 9327VB, exp. date 07/31/2021, original lot # R73995 0017DA, exp. date 07/31/2021, original lot # R73995 9353WA, exp. date 07/31/2021, original lot # R73995

Distribution pattern

Product was distributed throughout the United States, including Puerto Rico.

drug · product 5 of 5

Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB

D-1069-2020
Recall number
D-1069-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
4,104 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Code information

Batch/Lot # Lot # 0198FR, original lot # R53074, exp. date 10/31/2020 Lot # 3188FRB, original lot # R53074, exp. date 10/31/2020

Distribution pattern

Product was distributed throughout the United States, including Puerto Rico.