CLASS II Drug recall · Reported 29 Jun 2022 · FDA Enforcement Report

Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals USA

Teva Pharmaceuticals USA is recalling Tretinoin Capsules, 10 mg, distributed nationwide in the US. The recall was initiated on 14 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023

Quantity recalled4941 bottles

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-1156-2022
FDA event ID: 90430
Recalling firm: Teva Pharmaceuticals USA, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 14 Jun 2022
FDA classified: 23 Jun 2022
Reported: 29 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

14 Jun 2022	Recall initiated by company
23 Jun 2022	Classified by FDA	+9 days
29 Jun 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

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

Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.

Where it was distributed

Nationwide in the U.S.

Nationwide

Questions about this recall

Is Tretinoin Capsules, 10 mg recalled?

Yes. Teva Pharmaceuticals USA recalled Tretinoin Capsules, 10 mg on 14 Jun 2022. The recall is Class II and its status is Terminated. Recall number D-1156-2022.

Why was it recalled?

Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

Which lots are affected?

Lot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023

Where was it sold?

Nationwide in the U.S.

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.

More recalls from Teva Pharmaceuticals USA

All 84

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride	Teva Pharmaceuticals USA	Other	Nationwide
13 May 2026Drug	CLASS II	Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate	Teva Pharmaceuticals USA	Sterility	Nationwide
29 Apr 2026Drug	CLASS II	Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
15 Apr 2026Drug	CLASS II	Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin	Teva Pharmaceuticals USA	Potency & Assay	4 states
15 Apr 2026Drug	CLASS II	Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin	Teva Pharmaceuticals USA	Potency & Assay	4 states

Other Tretinoin recalls

All 4

Reported	Class	Recall	Company	Reason	Where
9 Feb 2022Drug	CLASS II	Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals U	Potency & Assay	Nationwide
28 Feb 2018Drug	CLASS II	Tretinoin USP for prescription compounding recalled	American Pharmaceutical Ingredients	Potency & Assay	Nationwide
22 Mar 2017Drug	CLASS II	Tretinoin Cream in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide