CLASS II Drug recall · Reported 24 Apr 2013 · FDA Enforcement Report
Copaxone (glatiramer acetate injection), 20 mg recalled
Teva Pharmaceuticals USA is recalling Copaxone (glatiramer acetate injection), 20 mg, distributed nationwide in the US. The recall was initiated on 5 Dec 2012 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-249-2013
- FDA event ID
- 63819
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Brand
- Copaxone
- Manufacturer
- Teva Neuroscience, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2012
- FDA classified
- 12 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Dec 2012 | Recall initiated by company | |
| 12 Apr 2013 | Classified by FDA | +128 days |
| 24 Apr 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30
Where it was distributed
Nationwide
Questions about this recall
Is Copaxone (glatiramer acetate injection), 20 mg recalled?
Yes. Teva Pharmaceuticals USA recalled Copaxone (glatiramer acetate injection), 20 mg on 5 Dec 2012. The recall is Class II and its status is Terminated. Recall number D-249-2013.
Why was it recalled?
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Which lots are affected?
Lot P53847, Exp 01/14
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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Other Glatiramer recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Copaxone (glatiramer acetate injection), 20 mg/ pre-filled syringe recalledCopaxone | Teva Pharmaceuticals U | Particulate Matter | Nationwide |
| Drug | CLASS II | Copaxone (glatiramer acetate injection), 20mg/mL recalledCopaxone | Teva Pharmaceuticals USA | Other | Nationwide |