Estradiol — Class II drug recall D-1244-2020
Terminated recall by B & B Pharmaceuticals, Inc., reported 2020-04-22, distributed nationwide. cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
| Recall number | D-1244-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B & B Pharmaceuticals, Inc., Englewood, CO, United States |
| Recall initiated | 2020-04-14 |
| Classified | 2020-04-16 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2020-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 3,825 grams |
| Reason classes | foreign material, cgmp |
| NDC | 63275-9900-04, 63275-9900-05, 63275-9900-08 |
| Lot numbers | 18K26-BB02-PR00553 |
Product
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
Reason for recall
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1244-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.