CLASS II Drug recall · Reported 16 Sep 2020 · FDA Enforcement Report
Cephalexin for Oral Suspension, USP 250 mg recalled
Teva Pharmaceuticals USA is recalling Cephalexin for Oral Suspension, USP 250 mg per, For Reconstitution, For Oral Use Only, distributed nationwide in the US. The recall was initiated on 24 Aug 2020 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-0013-2021
- FDA event ID
- 86285
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Cephalexin
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2020
- FDA classified
- 2 Oct 2020
- Reported
- 16 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 24 Aug 2020 | Recall initiated by company | |
| 16 Sep 2020 | Published in enforcement report | +23 days |
| 2 Oct 2020 | Classified by FDA | +16 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S. and Puerto Rico.
Questions about this recall
Why was it recalled?
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Which lots are affected?
Lot #s: a) 30309862A, 30309863A, Exp. 08/2020; 30309928A, 30309929A, Exp. 09/2020; 30310029A, 30310030A, 30310033A, 30310034A, Exp. 10/2020; 30310035A, 30310079A, 30310080A, 30310081A, Exp. 11/2020; 30310134A, 30310135A, Exp. 01/2021; 30310182A, 30310183A, 30310210A, Exp. 02/2021; 30310211A, 30310246A, Exp. 03/2021; 30310282A, Exp. 04/2021; 30310290A, Exp. 05/2021; 30310394A, 30310395A, Exp.07/2021; 30310457A, Exp. 09/2021; 30310506A, 30310507A, Exp. 10/2021; 30310555A, 30310605A, Exp. 11/2021. b) 30309864A, 30309865A, Exp. 08/2020; 30309930A, 30309931A, Exp. 09/2020; 30309991A, 30309992A, 30310028A, Exp.10/2020; 30310036A, 30310037A, 30310038A, Exp. 11/2020; 30310082A, 30310083A, Exp. 12/2020; 30310136A, 30310137A, Exp. 01/2021; 30310184A, 30310185A, Exp. 02/2021; 30310212A, Exp. 03/2021; 30310303A, Exp. 04/2021; 30310327A, Exp. 06/2021; 30310396A, 30310407A, Exp. 08/2021; 30310445A, Exp. 09/2021; 30310556A, Exp. 10/2021.
Where was it sold?
Nationwide in the U.S. 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.
Other products in this recall event
2 other products · FDA event 86285| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cephalexin for Oral Suspension, USP 125 mg recalledCephalexin | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Cephalexin for Oral Suspension, USP 250 mg recalledCephalexin | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
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Other Cephalexin recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalledCephalexin | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalledCephalexin | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |