FDA Drug recall D-0342-2021
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Prefe…
- FDA Drug
- Class II
- ongoing
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Prefe… by Preferred Pharmaceuticals, citing failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related subs….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0342-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-12 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | CA |
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
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
Identifiers
| ndc | 68788-7529-1 |
|---|---|
| ndc | 68788-7529-2 |
| code_info | Lot #: B1121W, Exp.Date: 04/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0342-2021%22
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