Estriol USP Micronized (Letco Medical) – Subpotent (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601
Brand
Letco Medical LLC
Lot Codes / Batch Numbers
Lots: a) 1804030048 Exp. 06/06/2020, 1712270019, 1802160017 Exp. 08/06/2020, 1804300021, 1806270007, 1808090056, 1904290047 Exp. 04/16/2021, 1810190004, 1812200072, 1901250024 Exp. 08/13/2021, 1902190028, 1907260018 Exp 09/14/2021, b) 1804030049 Exp. 06/06/2020, 1712270020, 1802160018 Exp. 08/06/2020, 1804300022, 1806270008, 1808090057, 1904290048 Exp. 04/16/2021, 1810190005, 1812200073, 1901250025 Exp. 08/13/2021, 1902190029, 1907260019 Exp. 09/14/2021, c) 1802160022 Exp. 08/06/2020, 1810190009, 1812200077 Exp. 08/13/2021, 1907260023 Exp. 09/14/2021, d) 1804030050 Exp 06/06/2020, 1712270021, 1802160019 Exp. 08/06/2020, 1804300023, 1806270009, 1808090058, 1904290049 Exp 04/16/2021, 1810190006, 1812200074, 1901250026 Exp. 08/13/2021, 1902190030, 1907260020 Exp. 09/14/2021, e) 1802160021 Exp. 08/06/2020, 1804300025, 1806270011, 1808090060 Exp. 04/16/2021, 1810190008 Exp. 08/13/2021, 1812200076 Exp. 08/13/2021, 1901250028 Exp. 08/13/2021, 1902190031 Exp. 09/14/2021, 1907260022 Exp. 09/14/2021, f) 1712270022 Exp. 08/06/2020, 1802160020 Exp. 08/06/2020, 1804030051 Exp. 06/06/2020, 1804300024 Exp. 04/16/2021, 1806270010 Exp. 04/16/2021, 1808090059 Exp. 04/16/2021, 1810190007 Exp. 08/13/2021, 1812200075 Exp. 08/13/2021, 1901250027 Exp. 08/13/2021, 1904290050 Exp. 04/16/2021, 1907260021 Exp. 09/14/2021
Products Sold
Lots: a) 1804030048 Exp. 06/06/2020; 1712270019, 1802160017 Exp. 08/06/2020; 1804300021, 1806270007, 1808090056, 1904290047 Exp. 04/16/2021; 1810190004, 1812200072, 1901250024 Exp. 08/13/2021; 1902190028, 1907260018 Exp 09/14/2021; b) 1804030049 Exp. 06/06/2020; 1712270020, 1802160018 Exp. 08/06/2020; 1804300022, 1806270008, 1808090057, 1904290048 Exp. 04/16/2021; 1810190005, 1812200073, 1901250025 Exp. 08/13/2021; 1902190029, 1907260019 Exp. 09/14/2021; c) 1802160022 Exp. 08/06/2020; 1810190009, 1812200077 Exp. 08/13/2021; 1907260023 Exp. 09/14/2021; d) 1804030050 Exp 06/06/2020; 1712270021, 1802160019 Exp. 08/06/2020; 1804300023, 1806270009, 1808090058, 1904290049 Exp 04/16/2021; 1810190006, 1812200074, 1901250026 Exp. 08/13/2021; 1902190030, 1907260020 Exp. 09/14/2021; e) 1802160021 Exp. 08/06/2020; 1804300025, 1806270011, 1808090060 Exp. 04/16/2021; 1810190008 Exp. 08/13/2021; 1812200076 Exp. 08/13/2021; 1901250028 Exp. 08/13/2021; 1902190031 Exp. 09/14/2021; 1907260022 Exp. 09/14/2021; f) 1712270022 Exp. 08/06/2020; 1802160020 Exp. 08/06/2020; 1804030051 Exp. 06/06/2020; 1804300024 Exp. 04/16/2021; 1806270010 Exp. 04/16/2021; 1808090059 Exp. 04/16/2021; 1810190007 Exp. 08/13/2021; 1812200075 Exp. 08/13/2021; 1901250027 Exp. 08/13/2021; 1904290050 Exp. 04/16/2021; 1907260021 Exp. 09/14/2021
Letco Medical LLC is recalling Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-215 due to Subpotent. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026