CLASS II Drug recall · Reported 13 Jul 2016 · FDA Enforcement Report
Tazorac (tazarotene) Gel recalled by Allergan Sales
Allergan Sales is recalling Tazorac (tazarotene) Gel 05%, distributed nationwide in the US. The recall was initiated on 10 May 2016 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-1064-2016
- FDA event ID
- 74126
- Recalling firm
- Allergan Sales, Waco, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2016
- FDA classified
- 6 Jul 2016
- Reported
- 13 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 May 2016 | Recall initiated by company | |
| 6 Jul 2016 | Classified by FDA | +57 days |
| 13 Jul 2016 | 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 Content Uniformity Specifications.
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
Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Tazorac (tazarotene) Gel 05% recalled?
Yes. Allergan Sales recalled Tazorac (tazarotene) Gel 05% on 10 May 2016. The recall is Class II and its status is Terminated. Recall number D-1064-2016.
Why was it recalled?
Failed Content Uniformity Specifications.
Which lots are affected?
Lot #: a) 84172, b) 84173, Exp FEB/2017
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 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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