Cephalexin for Oral Suspension — Class II drug recall D-0342-2021
Ongoing recall by Preferred Pharmaceuticals, Inc., reported 2021-05-05, distributed in CA. Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufa
| Recall number | D-0342-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preferred Pharmaceuticals, Inc., Anaheim, CA, United States |
| Recall initiated | 2021-04-12 |
| Classified | 2021-04-26 |
| Reported by FDA | 2021-05-05 |
| Distributed | CA |
| Reason classes | specification failure |
| NDC | 68788-7529, 68788-7529-01, 68788-7529-02 |
| Lot numbers | B1121W |
| Expiration dates | 2022-04 |
Product
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1,
Reason for recall
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
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-0342-2021. 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.