CLASS III Drug recall · Reported 9 Feb 2022 · FDA Enforcement Report
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalled
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, distributed nationwide in the US. The recall was initiated on 7 Jan 2022 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-0522-2022
- FDA event ID
- 89368
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Mimvey
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Jan 2022
- FDA classified
- 2 Feb 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Hormones & Birth Control
Timeline
| 7 Jan 2022 | Recall initiated by company | |
| 2 Feb 2022 | Classified by FDA | +26 days |
| 9 Feb 2022 | 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
Mislabeling
Product as listed by the FDA
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Mislabeling
Which lots are affected?
Lot#: 100018610, Exp 03/2022; 100021521, Exp 09/2022; 100024575, Exp 01/2023
Where was it sold?
USA 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 89368| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey | Teva Pharmaceuticals USA | Labeling Errors | Nationwide |
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