CLASS III Drug recall · Reported 29 Jul 2020 · FDA Enforcement Report
Famotidine Injection, USP, 20 mg/ vial recalled by HF Acquisition Co
HF Acquisition Co is recalling Famotidine Injection, USP, 20 mg/ vial, distributed in Connecticut. The recall was initiated on 17 Jun 2020 and the FDA has classified it as Class III.
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-1392-2020
- FDA event ID
- 85916
- Recalling firm
- HF Acquisition Co, Mukilteo, WA
- Brand
- Famotidine
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Jun 2020
- FDA classified
- 21 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 17 Jun 2020 | Recall initiated by company | |
| 21 Jul 2020 | Classified by FDA | +34 days |
| 29 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12
Where it was distributed
The vials were distributed to one consignee located in CT.
Questions about this recall
Is Famotidine Injection, USP, 20 mg/ vial recalled?
Yes. HF Acquisition Co recalled Famotidine Injection, USP, 20 mg/ vial on 17 Jun 2020. The recall is Class III and its status is Terminated. Recall number D-1392-2020.
Why was it recalled?
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Which lots are affected?
Lot #: 6122639, Exp. Date 08/2021
Where was it sold?
The vials were distributed to one consignee located in CT.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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 HF Acquisition Co
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|---|---|---|---|---|---|
| Device | CLASS II | Sporetraq Mail-in Spore Testing Service, 12 Tests recalled | HF Acquisition Co | Sterility | Nationwide |
| Device | CLASS II | Sporetraq Mail-in Spore Testing Service, 52 Tests recalled | HF Acquisition Co | Sterility | Nationwide |
| Device | CLASS II | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests recalled | HF Acquisition Co | Sterility | 50 states |
| Drug | CLASS III | Glycopyrrolate Injection, USP 2mg/ML Vial recalled by HF Acquisition CoGlycopyrrolate | HF Acquisition Co | Packaging Defects | AZ, CA, TX |
| Device | CLASS II | HealthFirst Emergency Medical Kit recalled by HF Acquisition Co | HF Acquisition Co | Packaging Defects | 39 states |
Other Famotidine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS I | Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | Famotidine Tablets, USP, 20mg bottle within recalledFamotidine | Glenmark Therapeutics | Other | Nationwide |
| Drug | CLASS II | Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USAFamotidine | Aurobindo Pharma USA | Other | 4 states |
| Drug | CLASS III | Famotidine tablets, 10 mg recalled by Dr. Reddy's LaboratoriesFamotidine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |