FDA Drug recall D-0519-2018

Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4)

FDA Drug
Class II
terminated
Published 2018-02-28

On 2018-02-28 the FDA classified a Class II recall of Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4) by American Pharmaceutical Ingredients, citing CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0519-2018
Classification	Class II
Status	terminated
Initiated	2018-02-09
Published	2018-02-28
Last updated	2026-09-13 11:52 UTC
Company	American Pharmaceutical Ingredients
Distribution	US

Product

Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Reason

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

Identifiers

code_info	Lot #: a) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp… Lot #: a) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp. 08/31/2020 c) 050115-3, 050115-4, Exp. 03/31/2020; d) 021317-3R, Exp 12/31/2021; 050115-2, 050115-3, Exp. 03/31/2020; 101915-3, 101915-4,101915-5, Exp. 08/31/2020; e) 021317-2R, Exp. 12/31/2021; 050115-2, exp. 03/31/2020; 101915-1, 101915-2,101915-5, Exp. 08/31/2020; f) 021317-1R, 021317-2R,021317-3R, Exp. 12/31/2021; 050115-1, 050115-2, Exp. 03/31/2020; 101915-1, 101915-2, Exp. 08/31/2020.

code_info

Lot #: a) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp…

Lot #: a) 021317-4, Exp. 12/31/2021; b) 021317-2R, 021317-4, Exp. 12/31/2021; 050115-4, Exp. 3/31/2020; 101915-5, Exp. 08/31/2020 c) 050115-3, 050115-4, Exp. 03/31/2020; d) 021317-3R, Exp 12/31/2021; 050115-2, 050115-3, Exp. 03/31/2020; 101915-3, 101915-4,101915-5, Exp. 08/31/2020; e) 021317-2R, Exp. 12/31/2021; 050115-2, exp. 03/31/2020; 101915-1, 101915-2,101915-5, Exp. 08/31/2020; f) 021317-1R, 021317-2R,021317-3R, Exp. 12/31/2021; 050115-1, 050115-2, Exp. 03/31/2020; 101915-1, 101915-2, Exp. 08/31/2020.

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-0519-2018%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.