Medisca ESTRADIOL Recall: FDA Inspection Findings
Medisca recalls specific ESTRADIOL USP (Hemihydrate) products due to manufacturing deficiencies found during FDA inspection. Affected products include 100mg, 1g, and 5g doses with NDC codes listed.
Recall notice
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Contact the company
What happened, in plain English
Medisca is recalling specific ESTRADIOL USP (Hemihydrate) products after FDA inspectors found quality control issues during a recent inspection. This recall affects certain dosages and packaging that may be in use by patients requiring hormone therapy. Read more at govinfonow.com/recall/41772-medisca-estradiol-recall-fda-inspection-findings.
Source Summary by GovInfoNow · govinfonow.com/recall/41772-medisca-estradiol-recall-fda-inspection-findings · Updated October 8, 2026 · FDA enforcement record: FDA #D-0665-2017
Cite this page
“Medisca ESTRADIOL Recall: FDA Inspection Findings.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41772-medisca-estradiol-recall-fda-inspection-findings. Based on FDA recall #D-0665-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0665-2017%22&limit=1).
Why it’s dangerous
The recall was initiated by Medisca following FDA inspection findings of manufacturing quality control deviations. These deviations could potentially affect the product's safety and effectiveness, though the exact nature of the issues isn't specified in the recall notice.
Who’s affected
Patients using Medisca's ESTRADIOL USP (Hemihydrate) products for hormone therapy are affected. Those with the specific NDC codes listed in the recall are most at risk.
How to tell if you have this one
Check the product label for the NDC codes listed: 38779-0869-07 (100 mg), 38779-0869-06 (1 g), or 38779-0869-03 (5 g). Products were manufactured by Medisca Inc. in Plattsburgh, NY.
- Brand
Medisca- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
| Recall number | Product, codes & lots |
|---|---|
| D-0663-2017 | ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732; a) 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I b) 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D,138646/H c) 126317/B,127288/A,127296/B, 136212/A, 137155/A, 137156/A,138638/A, 138646/C, 138646/G, 141219/A d) 126317/A, 127296/A, 138646/F |
| D-0664-2017 | ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891; a) 124880/D,124880/O, 130940/J, 135312/E b) 124880/C 124880/F 124880/I 124880/N 130940/D 130940/I 135312/D 135312/I 136546/D 139489/B c) 124880/B, 124880/H, 124880/M, 130940/C, 130940/H, 135312/C, 135312/H, 136546/C d) 124880/A ,130940/B, 130940/G, 135312/B, 135312/G, 136546/B, 139489/A e) 124880/G, 124880/J, 124880/L,130940/A, 130940/F, 135312/A, 135312/F, 136546/A |
| D-0665-2017 | ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869; a) 137169/F b) 129670/G, 129670/K, 130942/G, 130942/L, 131429/G, 131430/G, 137169/E c) 129670/F,129670/J, 130942/F, 130942/K 131429/F, 131430/F, 137169/D, d) 129670/E, 129670/I,130942/E, 130942/J,131429/E, 131430/E, 137169/C e) 129670/D, 129670/H, 130942/D, 130942/I, 131429/D, 131430/D, 131430/H, 137169/B f) 129670/C, 130942/C, 130942/H, 131429/C, 131430/C, 137169/A, 137169/F g) 129670/B, 130942/B, 131429/B, 131430/B h) 129670/A, 130942/A ,131429/A, 131430/A |
| D-0666-2017 | ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261; a) 129669/C, 129669/F, 129669/H, 129669/J, 130941/B 130941/D, 130941/F, 136108/B, 139091/B; b) 129669/B, 129669/E, 130941/A, 130941/C, 130941/E,130941/G, 136108/A, |
What to do — step by step
Check Product Label
Look for NDC codes 38779-0869-07 (100 mg), 38779-0869-06 (1 g), or 38779-0869-03 (5 g) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0665-2017 (April 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0665-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.