Class II · Moderate risk
fentaNYL Citrate
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Fentanyl Citrate USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Affected NDC
49452-0032-06
Compare with the code on your package — it is the most precise check available.
Drug: Fentanyl
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Fentanyl Citrate NDC 49452-0032 |
1 g/g | Crystal | Spectrum Chemical and Laboratory Products | BULK INGREDIENT · CII |
- Recalling firm
- Spectrum Laboratory Products
- NDC code
- 49452-0032-06
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0141-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fentanyl recalls
See all
Class II · Moderate risk
fentaNYL Citrate
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Other recalls by Spectrum Laboratory Products
All 2019 recalls
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class II · Moderate risk
Ranitidine Hydrochloride
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Estriol
Subpotent Drug: Supplier indicated assay results did not meet specifications.
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