CLASS III Drug recall · Reported 29 Oct 2014 · FDA Enforcement Report

MethylPREDNISolone Tablets, USP, 4 mg dose blisters, Packaged recalled

American Health Packaging is recalling MethylPREDNISolone Tablets, USP, 4 mg dose blisters, Packaged, distributed nationwide in the US. The recall was initiated on 10 Oct 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesAHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11

NDC68084-149

Quantity recalled2,005 cartons

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-0043-2015
FDA event ID: 69511
Recalling firm: American Health Packaging, Columbus, OH
Brand: Methylprednisolone
Manufacturer: American Health Packaging
Classification: Class III
Status: Terminated
Recall initiated: 10 Oct 2014
FDA classified: 23 Oct 2014
Reported: 29 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

10 Oct 2014	Recall initiated by company
23 Oct 2014	Classified by FDA	+13 days
29 Oct 2014	Published in enforcement report	+6 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, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent; 6 month stability time point

Which lots are affected?

AHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11

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 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.

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22 Feb 2023Drug	CLASS II	Methylprednisolone 12MG IN NS Syringe, steroid recalled	Sentara Infusion Services	Sterility	Nationwide