Pfizer Recalls Depo-Medrol Vials Due to pH Specification Failure
Pfizer is recalling 93,800 vials of Depo-Medrol (methylprednisolone acetate) because a stability test showed a pH level below the registered specification.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or specification issues without reported harm.
Plain-English summary
Pfizer Inc. is recalling 93,800 vials of Depo-Medrol (methylprednisolone acetate) injectable suspension, 40 mg/mL, 1 mL single-dose vials. The affected products are distributed nationwide and include Lot H43272 and H43265, which have an expiration date of 09/14.
The recall was initiated because a pH result of 2.9 was obtained at the 9-month stability test interval at 25C/60%RH. This result falls below the registered specification for pH, which is 3.0 - 7.0.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare providers and patients should discontinue use of the affected lots and contact Pfizer for further instructions.
The recalled product
- Product
- DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
- Brand
- DEPO-MEDROL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 93,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot H43272
- H43265 Exp. 09/14
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DEPO-MEDROL
- HighFDA Recalls Depo-Medrol Injectable Due to Temperature Abuse in Manufacturing
FDA (Drugs) · 2022-06-15
- ModerateDepo-Medrol injectable suspension recalled for manufacturing temperature control deviations
FDA (Drugs) · 2022-06-15
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Same hazard · ph specification failure
See all →- LowOasis Medical Recalls HPMC Visoelastic Topical Due to pH Specification Failure
FDA (Drugs) · 2015-12-30
- LowOasis Medical Recalls HPMC Visoelastic Due to Potential pH Specification Failure
FDA (Drugs) · 2015-12-30
- LowHospira Recalls Carboplatin Injection Vials Due to pH Specification Failure
FDA (Drugs) · 2012-08-22