CLASS III Drug recall · Reported 1 Oct 2014 · FDA Enforcement Report
MethylPREDNISolone Tablets, USP 4 mg, a) bottles recalled
Qualitest Pharmaceuticals is recalling MethylPREDNISolone Tablets, USP 4 mg, a) bottles (, distributed nationwide in the US. The recall was initiated on 11 Sep 2014 and the FDA has classified it as Class III.
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-1605-2014
- FDA event ID
- 69233
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Brand
- Methylprednisolone
- Manufacturer
- Par Health USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Sep 2014
- FDA classified
- 22 Sep 2014
- Reported
- 1 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 11 Sep 2014 | Recall initiated by company | |
| 22 Sep 2014 | Classified by FDA | +11 days |
| 1 Oct 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; 6 month stability time point
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Where it was distributed
Nationwide
Questions about this recall
Is MethylPREDNISolone Tablets, USP 4 mg, a) bottles ( recalled?
Yes. Qualitest Pharmaceuticals recalled MethylPREDNISolone Tablets, USP 4 mg, a) bottles ( on 11 Sep 2014. The recall is Class III and its status is Terminated. Recall number D-1605-2014.
Why was it recalled?
Subpotent; 6 month stability time point
Which lots are affected?
100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Methylprednisolone recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate | Eugia US | Potency & Assay | 4 states |
| Drug | CLASS II | Depo-Medrol (methylprednisolone acetate injectable recalledDepo-medrol | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Depo-Medrol (methylprednisolone acetate injectable recalledDepo-medrol | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |