CLASS II Drug recall · Reported 1 Jan 2020 · FDA Enforcement Report
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol recalled
Spectrum Laboratory Products is recalling Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol, distributed nationwide in the US. The recall was initiated on 11 Dec 2019 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-0628-2020
- FDA event ID
- 84509
- Recalling firm
- Spectrum Laboratory Products, Gardena, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2019
- FDA classified
- 23 Dec 2019
- Reported
- 1 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 11 Dec 2019 | Recall initiated by company | |
| 23 Dec 2019 | Classified by FDA | +12 days |
| 1 Jan 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.
Where it was distributed
Nationwide in the USA and Canada
Questions about this recall
Is Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol recalled?
Yes. Spectrum Laboratory Products recalled Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol on 11 Dec 2019. The recall is Class II and its status is Terminated. Recall number D-0628-2020.
Why was it recalled?
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Which lots are affected?
Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021
Where was it sold?
Nationwide in the USA and Canada
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 Spectrum Laboratory Products
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS recalled | Spectrum Laboratory Products | Foreign Material | Nationwide |
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS 51-43-4 amber recalled | Spectrum Laboratory Products | Foreign Material | Nationwide |
| Drug | CLASS II | Ranitidine Hydrochloride (powder) recalled | Spectrum Laboratory Products | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Fentanyl Citrate USP, Active Pharmaceutical Ingredient recalled | Spectrum Laboratory Products | Foreign Material | 4 states |
| Drug | CLASS II | Levonorgestrel, U.S.P recalled by Spectrum Laboratory Products | Spectrum Laboratory Products | Manufacturing (CGMP) Deviations | Nationwide |