Spectrum Estradiol Product Recall: CGMP Deviations Risk
Spectrum Laboratory Products recalls estradiol products due to FDA-inspected CGMP deviations. These repackaged pharmaceutical ingredients may not meet safety standards. Affected units include 1g, 5g, 25g, 6x25g, and 100g containers with specific lot numbers.
Recall notice
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Contact the company
What happened, in plain English
Spectrum Laboratory Products is recalling estradiol products that were repackaged and redistributed due to deviations in current Good Manufacturing Practices found during an FDA inspection. This recall affects specific lot numbers and container sizes sold under the brand. Read more at govinfonow.com/recall/41756-spectrum-estradiol-product-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41756-spectrum-estradiol-product-recall-cgmp-deviations-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0881-2017
Cite this page
“Spectrum Estradiol Product Recall: CGMP Deviations Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41756-spectrum-estradiol-product-recall-cgmp-deviations-risk. Based on FDA recall #D-0881-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0881-2017%22&limit=1).
Why it’s dangerous
The products were repackaged and redistributed after an FDA inspection found deviations from current Good Manufacturing Practices. These deviations could potentially affect the safety and quality of the pharmaceutical ingredient.
Who’s affected
Prescription users of estradiol products in specific container sizes and lot numbers. Individuals with medical prescriptions for this hormone may be affected.
How to tell if you have this one
Check for 1g, 5g, 25g, 6x25g, or 100g containers with lot numbers 2FH0257 (expiring 09/30/2017) or 2GA0254 (expiring 03/24/2018).
- Brand
Spectrum Laboratory Products- Category
Drug
All 2 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 in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0881-2017 | Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.; Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018 | 48 containers |
| D-0882-2017 | Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.; Lot #: 2FD0376, Exp 02/21/21 | 1 container |
What to do — step by step
Check Product Details
Identify the container size and lot number to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months 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.
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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-0881-2017 (April 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0881-2017 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.