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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Letco Medical LLC: Estriol USP Micronized Recalled for Being Subpotent

Agency Publication Date: January 15, 2020
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Summary

Letco Medical LLC is recalling approximately 3,685 jars of Estriol USP Micronized, a prescription hormone therapy medication, because it was found to be subpotent. Subpotent means the product does not contain the full strength of the active ingredient listed on the label, which can lead to ineffective treatment and the return of symptoms. This recall affects various sizes ranging from 1 gram to 1 kilogram that were distributed between 2017 and 2020. Consumers should contact their healthcare provider or pharmacist for guidance on their treatment plan.

Risk

The medication contains less than the required amount of the active ingredient, which may result in patients receiving a lower dose than prescribed. This lack of full potency can cause the medication to fail in treating the patient's condition effectively.

What You Should Do

  1. Check your medication jar to see if it is Estriol USP Micronized with any of the following NDC numbers: 62991-2159-04 (100g), 62991-2159-01 (1g), 62991-2159-06 (1kg), 62991-2159-03 (25g), 62991-2159-05 (500g), or 62991-2159-02 (5g).
  2. Verify the lot number and expiration date on the label. Affected lots include 1804030048, 1712270019, 1802160017, 1804300021, 1806270007, 1808090056, 1904290047, 1810190004, 1812200072, 1901250024, 1902190028, 1907260018, and many others with expiration dates between June 2020 and September 2021.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement medication is needed.
  4. Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.
  5. Contact Letco Medical LLC at 1316 Commerce Dr, Decatur, Alabama, 35601 for further instructions regarding the return of the product.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund or medication replacement

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Estriol USP Micronized (100 gm)
Model:
NDC 62991-2159-04
Lot Numbers:
1804030048 (Exp. 06/06/2020)
1712270019 (Exp. 08/06/2020)
1802160017 (Exp. 08/06/2020)
1804300021 (Exp. 04/16/2021)
1806270007 (Exp. 04/16/2021)
1808090056 (Exp. 04/16/2021)
1904290047 (Exp. 04/16/2021)
1810190004 (Exp. 08/13/2021)
1812200072 (Exp. 08/13/2021)
1901250024 (Exp. 08/13/2021)
1902190028 (Exp. 09/14/2021)
1907260018 (Exp. 09/14/2021)
Product: Estriol USP Micronized (1 gm)
Model:
NDC 62991-2159-01
Lot Numbers:
1804030049 (Exp. 06/06/2020)
1712270020 (Exp. 08/06/2020)
1802160018 (Exp. 08/06/2020)
1804300022 (Exp. 04/16/2021)
1806270008 (Exp. 04/16/2021)
1808090057 (Exp. 04/16/2021)
1904290048 (Exp. 04/16/2021)
1810190005 (Exp. 08/13/2021)
1812200073 (Exp. 08/13/2021)
1901250025 (Exp. 08/13/2021)
1902190029 (Exp. 09/14/2021)
1907260019 (Exp. 09/14/2021)
Product: Estriol USP Micronized (1 kg)
Model:
NDC 62991-2159-06
Lot Numbers:
1802160022 (Exp. 08/06/2020)
1810190009 (Exp. 08/13/2021)
1812200077 (Exp. 08/13/2021)
1907260023 (Exp. 09/14/2021)
Product: Estriol USP Micronized (25 gm)
Model:
NDC 62991-2159-03
Lot Numbers:
1804030050 (Exp 06/06/2020)
1712270021 (Exp. 08/06/2020)
1802160019 (Exp. 08/06/2020)
1804300023 (Exp 04/16/2021)
1806270009 (Exp 04/16/2021)
1808090058 (Exp 04/16/2021)
1904290049 (Exp 04/16/2021)
1810190006 (Exp. 08/13/2021)
1812200074 (Exp. 08/13/2021)
1901250026 (Exp. 08/13/2021)
1902190030 (Exp. 09/14/2021)
1907260020 (Exp. 09/14/2021)
Product: Estriol USP Micronized (500 gm)
Model:
NDC 62991-2159-05
Lot Numbers:
1802160021 (Exp. 08/06/2020)
1804300025 (Exp. 04/16/2021)
1806270011 (Exp. 04/16/2021)
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)
Product: Estriol USP Micronized (5 gm)
Model:
NDC 62991-2159-02
Lot Numbers:
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)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84686
Status: Resolved
Manufacturer: Letco Medical LLC
Sold By: Pharmacies; Hospitals; Compounding Centers
Manufactured In: United States
Units Affected: a) 597 jars; b) 411 jars; c) 5 jars; d) 1004 jars: e) 76 jars; f) 1592 jars
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.