Cephalexin for Oral Suspension — Class II drug recall D-0013-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2020-09-16, distributed nationwide. CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above a
| Recall number | D-0013-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2020-08-24 |
| Classified | 2020-10-02 |
| Reported by FDA | 2020-09-16 |
| Terminated | 2021-12-16 |
| Distributed | Nationwide (US) |
| Quantity | 1,467,535 bottles |
| Reason classes | cgmp |
| NDC | 00093-3145, 00093-3145-01, 00093-3145-05, 00093-3147, 00093-3147-01, 00093-3147-05, 00093-4175, 00093-4175-73, 00093-4175-74, 00093-4177, 00093-4177-73, 00093-4177-74 |
| Expiration dates | 2020-08, 2020-09, 2020-10, 2020-11, 2020-12, 2021-01, 2021-02, 2021-03, 2021-04, 2021-05, 2021-06, 2021-07, 2021-08, 2021-09, 2021-10, 2021-11 |
Product
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Reason for recall
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
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-0013-2021. 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.