Fentanyl Citrate USP — Class II drug recall D-0141-2020
Terminated recall by Spectrum Laboratory Products, reported 2019-10-23, distributed in CA, CO, MD, SC. CGMP Deviations: Received notice from supplier that there is potential glass contamination.
| Recall number | D-0141-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectrum Laboratory Products, Gardena, CA, United States |
| Recall initiated | 2019-09-12 |
| Classified | 2019-10-15 |
| Reported by FDA | 2019-10-23 |
| Terminated | 2020-11-10 |
| Distributed | CA, CO, MD, SC |
| Quantity | 29.1 grams |
| Reason classes | foreign material, cgmp |
| NDC | 49452-0032-06 |
| Lot numbers | 1HE0899, 1IB0005 |
| Expiration dates | 2023-02-28 |
Product
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Reason for recall
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
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-0141-2020. 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.