CLASS II Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report
Estriol USP Micronized a) 100 gm recalled by Letco Medical
Letco Medical is recalling Estriol USP Micronized a) 100 gm. The recall was initiated on 10 Jan 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0780-2020
- FDA event ID
- 84686
- Recalling firm
- Letco Medical, Decatur, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2020
- FDA classified
- 15 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 10 Jan 2020 | Recall initiated by company | |
| 15 Jan 2020 | Classified by FDA | +5 days |
| 22 Jan 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
United States, Australia, Canada, Israel, Philippines, Taiwan.
Questions about this recall
Is Estriol USP Micronized a) 100 gm recalled?
Yes. Letco Medical recalled Estriol USP Micronized a) 100 gm on 10 Jan 2020. The recall is Class II and its status is Terminated. Recall number D-0780-2020.
Why was it recalled?
Subpotent
Which lots are affected?
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
Where was it sold?
United States, Australia, Canada, Israel, Philippines, Taiwan.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Letco Medical
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Espumil, Lipophilic foam base, 24G15-T02 recalled by Letco Medical | Letco Medical | Other | AL |
Other Estriol recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estriol USP41 Micro recalled by API Solutions | API Solutions | Manufacturing (CGMP) Deviations | 5 states |
| Drug | CLASS II | Estriol USP Micronized recalled by Triova Pharmaceuticals | Triova Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Estriol USP (Micronized) (Yam) for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Estriol Gels, Rx, compounded by Life Science Pharmacy Inc. recalled | Life Science Pharmacy | Other | Nationwide |
| Drug | CLASS II | Estriol Creams, Rx, compounded by Life Science Pharmacy recalled | Life Science Pharmacy | Other | Nationwide |