CLASS III Drug recall · Reported 17 Apr 2013 · FDA Enforcement Report
Portia (levonorgestrel and ethinyl estradiol) Tablets recalled
Teva Pharmaceuticals USA is recalling Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0, distributed nationwide in the US. The recall was initiated on 12 Mar 2013 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-245-2013
- FDA event ID
- 64607
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Brand
- Portia
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Mar 2013
- FDA classified
- 10 Apr 2013
- Reported
- 17 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 12 Mar 2013 | Recall initiated by company | |
| 10 Apr 2013 | Classified by FDA | +29 days |
| 17 Apr 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
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
Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Which lots are affected?
Lot #: 33801951A, and 33802189A, Exp 03/13
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 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.
Other products in this recall event
1 other product · FDA event 64607This product is part of a recall event; the main page for the event is Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0 recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
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Other Levonorgestrel recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levonorgestrel and Ethinyl Estradiol Tablets recalled | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg recalled | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Altavera Levonorgestrel and Ethinyl Estradiol Tablets recalledAltavera | Xiromed | Labeling Errors | Nationwide |
| Drug | CLASS II | Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive recalledOption 2 | L. Perrigo | Other | Nationwide |
| Drug | CLASS III | Lessina(R) (Levonorgestrel and ethinyl estradiol tablets recalledLessina | Teva Pharmaceuticals USA | Benzene | Nationwide |