Amoxicillin and Clavulanate Potassium for Oral Suspension — Class II drug recall D-1125-2017
Terminated recall by Morton Grove Pharmaceuticals, Inc., reported 2017-09-06, distributed nationwide. Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitril
| Recall number | D-1125-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, United States |
| Recall initiated | 2017-08-10 |
| Classified | 2017-08-29 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2018-09-13 |
| Distributed | Nationwide (US) |
| Quantity | 7,332 bottles |
| Reason classes | foreign material |
| NDC | 60432-0065-00 |
| Lot numbers | 10/18, KH60276 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1125-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.