Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 08-24-2020 for the product Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. The product was recalled due to cgmp deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0012-2021 | 08-24-2020 | 09-16-2020 | Class II | 103,940 bottles | Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. | Terminated |
| D-1566-2020 | 08-24-2020 | 09-16-2020 | Class II | 38,487 bottles | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73. | Sub-Potent Drug: Out of specification test results for potency (below specification). | Terminated |
| D-0013-2021 | 08-24-2020 | 09-16-2020 | Class II | 1,467,535 bottles | 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. | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0093-3145 | Cephalexin | | | | Teva Pharmaceuticals Usa, Inc. | |
| 0093-3145 | Cephalexin | Cephalexin | Capsule | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
| 0093-3147 | Cephalexin | | | | Teva Pharmaceuticals Usa, Inc. | |
| 0093-3147 | Cephalexin | Cephalexin | Capsule | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
| 0093-4175 | Cephalexin | | | | Teva Pharmaceuticals Usa, Inc. | |
| 0093-4175 | Cephalexin | Cephalexin | Powder, For Suspension | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
| 0093-4177 | Cephalexin | | | | Teva Pharmaceuticals Usa, Inc. | |
| 0093-4177 | Cephalexin | Cephalexin | Powder, For Suspension | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
