Spectrum Laboratory Products Recalls Subpotent Estriol Micronized USP
Spectrum Laboratory Products is recalling specific lots of Estriol Micronized USP because assay results did not meet specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a subpotent drug where no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Spectrum Laboratory Products is voluntarily recalling 6.284 kg of Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP. The affected product is packaged in 1 g, 5 g, 25 g, 100 g, 500 g glass bottles and 1 kg plastic bottles and is marked as Rx Only. The recall covers lots 1HG0308, 1HH0630, 1HI0854, 4HL0005, 4HL0036, and 4IH0032, all with an expiration date of 04/16/2021.
The recall was initiated because the supplier indicated that assay results for the product did not meet specifications, classifying it as a subpotent drug. The product was distributed nationwide in the USA and Canada.
Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Spectrum Laboratory Products
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #s: 1HG0308
- 1HH0630
- 1HI0854
- 4HL0005
- 4HL0036
- 4IH0032
- Exp. 04/16/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Spectrum Laboratory Products
See all →- SevereSpectrum Chemical Recalls Ranitidine Hydrochloride Powder Due to NDMA Impurity
FDA (Drugs) · 2020-02-12
- HighSpectrum Chemical Recalls Fentanyl Citrate Due to Glass Contamination
FDA (Drugs) · 2019-10-23
- ModerateSpectrum Laboratory Products Recalls Tetrahydrozoline Hydrochloride Due to CGMP Deviations
FDA (Drugs) · 2014-11-26
Same hazard · subpotent drug
See all →- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02