CLASS III Drug recall · Reported 1 Jul 2015 · FDA Enforcement Report
Lutera 1 mg levonorgestrel and USP) recalled by Actavis
Actavis is recalling Lutera 1 mg levonorgestrel and USP), 28 day Regimen Dispensers per box Each, distributed nationwide in the US. The recall was initiated on 4 Jun 2015 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-1148-2015
- FDA event ID
- 71495
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Jun 2015
- FDA classified
- 24 Jun 2015
- Reported
- 1 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 4 Jun 2015 | Recall initiated by company | |
| 24 Jun 2015 | Classified by FDA | +20 days |
| 1 Jul 2015 | 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
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
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
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Lutera 1 mg levonorgestrel and USP), 28 day Regimen Dispensers per box Each recalled?
Yes. Actavis recalled Lutera 1 mg levonorgestrel and USP), 28 day Regimen Dispensers per box Each on 4 Jun 2015. The recall is Class III and its status is Terminated. Recall number D-1148-2015.
Why was it recalled?
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Which lots are affected?
Lot #s: KPPY, Exp 06/15; NBXD, NBXF, Exp 10/16; NBXG, Exp 09/15; NKZS, Exp 11/15; NMPT, NNXB, NNWG, Exp 01/16; NMPV, NVWN, NVWP, Exp 02/16; NMTP, NNXC, Exp 03/16; NMWC, NNXH, Exp 04/16; PFHT, PFHW, PFHX, Exp 06/16; PKHH, PKHN, PKHS, PKHT, PPGG, PPGH, PVSZ, Exp 08/16; PYDX, Exp 09/16.
Where was it sold?
Nationwide and Puerto Rico
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 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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