CLASS III Drug recall · Reported 4 Oct 2017 · FDA Enforcement Report
Ampicillin for Injection, USP, 500 mg per vial, single vial recalled
Sandoz is recalling Ampicillin for Injection, USP, 500 mg per vial, single vial (, distributed nationwide in the US. The recall was initiated on 25 Sep 2017 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-1179-2017
- FDA event ID
- 78169
- Recalling firm
- Sandoz, Princeton, NJ
- Brand
- Ampicillin
- Manufacturer
- Sandoz Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Sep 2017
- FDA classified
- 28 Sep 2017
- Reported
- 4 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 25 Sep 2017 | Recall initiated by company | |
| 28 Sep 2017 | Classified by FDA | +3 days |
| 4 Oct 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Product as listed by the FDA
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Which lots are affected?
Lot: GH8254, Exp 06/19
Where was it sold?
Nationwide in the USA and Puerto Rico
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 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.
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Other Ampicillin recalls
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP 500 mg per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |