Depo-Medrol — Class III drug recall D-1537-2014
Terminated recall by Pfizer Inc., reported 2014-08-20, distributed nationwide. Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH.
| Recall number | D-1537-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2014-07-30 |
| Classified | 2014-08-12 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2017-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 93,800 vials |
| Reason classes | specification failure |
| NDC | 00009-3073, 00009-3073-01, 00009-3073-03, 00009-3073-22, 00009-3073-23, 00009-3475, 00009-3475-01, 00009-3475-03, 00009-3475-22, 00009-3475-23 |
| Lot numbers | 09/14, H43265, H43272 |
Product
Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23
Reason for recall
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
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-1537-2014. 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.