CLASS II Drug recall · Reported 17 Aug 2016 · FDA Enforcement Report
Zinc Acetate, Crystal recalled by Spectrum Laboratory Products
Spectrum Laboratory Products is recalling Zinc Acetate, Crystal, USP, distributed in Georgia, Massachusetts, Missouri, Tennessee. The recall was initiated on 1 Aug 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1456-2016
- FDA event ID
- 74888
- Recalling firm
- Spectrum Laboratory Products, New Brunswick, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Aug 2016
- FDA classified
- 10 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
Timeline
| 1 Aug 2016 | Recall initiated by company | |
| 10 Aug 2016 | Classified by FDA | +9 days |
| 17 Aug 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
Where it was distributed
US: MA, TN, GA, MO and Canada
Questions about this recall
Why was it recalled?
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Which lots are affected?
Lot # 2EH0257
Where was it sold?
US: MA, TN, GA, MO and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Spectrum Laboratory Products
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS 51-43-4 amber recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Ranitidine Hydrochloride (powder) recalled | Spectrum Laboratory Products | Nitrosamine Impurity | 11 states |
| Drug | CLASS II | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol recalled | Spectrum Laboratory Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Fentanyl Citrate USP, Active Pharmaceutical Ingredient recalled | Spectrum Laboratory Products | Foreign Material | 4 states |
Other Zinc recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zicam" Medicated Fruit Drops Elderberry Flavor, 25-drops recalledZicam Cold Remedy Medicated Fruit Drops - Elderberry | Church & Dwight | Packaging Defects | Nationwide |
| Drug | CLASS II | Zinc Sulfate for Injection, all strengths and presentations recalled | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Zinc Sulfate 1MG/ML Injection Solution (Pfv) per Vial recalled | RXQ Compounding | Sterility | Nationwide |
| Drug | CLASS II | Zinc Sulfate 1MG/ML Injection Solution per Vial recalled | RXQ Compounding | Sterility | Nationwide |
| Drug | CLASS II | Zinc Sulfate,10mg/ml injection vial recalled by Promise Pharmacy | Promise Pharmacy | Sterility | Nationwide |