CLASS II Drug recall · Reported 6 Sep 2017 · FDA Enforcement Report
Amoxicillin and Clavulanate Potassium for Oral Suspension recalled
Morton Grove Pharmaceuticals is recalling Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per (when, distributed nationwide in the US. The recall was initiated on 10 Aug 2017 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-1125-2017
- FDA event ID
- 77933
- Recalling firm
- Morton Grove Pharmaceuticals, Morton Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2017
- FDA classified
- 29 Aug 2017
- Reported
- 6 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Antibiotics
Timeline
| 10 Aug 2017 | Recall initiated by company | |
| 29 Aug 2017 | Classified by FDA | +19 days |
| 6 Sep 2017 | 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
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Which lots are affected?
Batch #: KH60276, Exp 10/18
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 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 Morton Grove Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Elixir, USP 0.5 mg/, Net recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Promethazine Syrup Plain, 6.25 mg recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Valproic Acid Oral Solution USP, (250 mg/, 1 Pint recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Promethazine With Codeine Oral Solution recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
Other Amoxicillin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amoxicillin and Clavulanate Potassium recalled | Teva Pharmaceuticals USA | Potency & Assay | CA, MS, OH |
| Drug | CLASS II | Amoxicillin and Clavulanate Potassium Tablets recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 400MG/ (when reconstituted) recalledAmoxicillin | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin Tablets, USP, 875MG recalled by Cardinal HealthcareAmoxicillin | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin Capsules, USP, 500 mg recalled by Mckesson Medical-SurgicalAmoxicillin | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |