CLASS II Drug recall · Reported 15 Aug 2012 · FDA Enforcement Report
Copaxone (glatiramer acetate injection), 20mg/mL recalled
Teva Pharmaceuticals USA is recalling Copaxone (glatiramer acetate injection), 20mg/mL, distributed nationwide in the US. The recall was initiated on 18 May 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-1442-2012
- FDA event ID
- 62241
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Brand
- Copaxone
- Manufacturer
- Teva Neuroscience, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2012
- FDA classified
- 3 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 18 May 2012 | Recall initiated by company | |
| 3 Aug 2012 | Classified by FDA | +77 days |
| 15 Aug 2012 | 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: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Product as listed by the FDA
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Which lots are affected?
Lot number X05011, Exp 08/13
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 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.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Glatiramer recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glatiramer Acetate 40 mg/mL recalled by Kroger Specialty Pharmacy | Kroger Specialty Pharmacy | Other | 5 states |
| Drug | CLASS II | Copaxone (glatiramer acetate injection), 20 mg/ pre-filled syringe recalledCopaxone | Teva Pharmaceuticals USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Copaxone (glatiramer acetate injection), 20 mg recalledCopaxone | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |