CLASS II Drug recall · Reported 8 Jul 2015 · FDA Enforcement Report
Oxycodone HCl C-ii Tablets, 5 mg USP blister cards recalled
The Harvard Drug Group is recalling Oxycodone HCl C-ii Tablets, 5 mg USP blister cards, distributed nationwide in the US. The recall was initiated on 10 Jun 2015 and the FDA has classified it as Class II.
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-1150-2015
- FDA event ID
- 71454
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2015
- FDA classified
- 29 Jun 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 10 Jun 2015 | Recall initiated by company | |
| 29 Jun 2015 | Classified by FDA | +19 days |
| 8 Jul 2015 | 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
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
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
OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61.
Where it was distributed
Nationwide
Questions about this recall
Is Oxycodone HCl C-ii Tablets, 5 mg USP blister cards recalled?
Yes. The Harvard Drug Group recalled Oxycodone HCl C-ii Tablets, 5 mg USP blister cards on 10 Jun 2015. The recall is Class II and its status is Terminated. Recall number D-1150-2015.
Why was it recalled?
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Which lots are affected?
Lot # P-20000; Exp. 08/16 Lot # P-20004; Exp. 08/16
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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|---|---|---|---|---|---|
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