Teva Isotretinoin 40 mg Superpotent/Subpotent Recall Affects 8,376 Packages
Summary
FDA classified a Class II recall by Teva Pharmaceuticals USA, Inc. for Isotretinoin Capsules, USP, 40 mg (NDC 0591-2436-15, 0591-2436-45) after discovering superpotent and subpotent dosage issues in three lots. The recall covers 8,376 packages across lots 100075305 (Exp 06/2027), 100075512 (Exp 07/2027), and 100076103 (Exp 07/2027). Distribution was limited to Florida, Ohio, Puerto Rico, and Mississippi.
What changed
FDA classified a Class II drug recall initiated by Teva Pharmaceuticals USA, Inc. for Isotretinoin Capsules, USP, 40 mg after identifying superpotent and subpotent content variability across three lots totaling 8,376 packages. The affected lots — 100075305, 100075512, and 100076103 — were distributed exclusively to Florida, Ohio, Puerto Rico, and Mississippi.\n\nHealthcare providers and patients in the affected distribution states should verify their inventory against the listed lot numbers. Because isotretinoin carries a boxed warning for embryo-fetal toxicity, potency inconsistency in either direction carries heightened clinical significance. Pharmacies and prescribing dermatologists should consider whether patients may have received affected stock and determine whether dosage reassessment is warranted.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Teva Pharmaceuticals USA, Inc
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0446-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister ...
Reason for Recall
Superpotent and Subpotent
Affected Lot Numbers / Codes
Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
Quantity
8376 packages
Firm Notification Method
Letter
Distribution
FL, OH, PR & MS
Initiated
20260112
FDA Classified
20260408
Product Registration
Brand: ISOTRETINOIN
Manufacturer: Actavis Pharma, Inc.
Application: ANDA205063
NDC: 0591-2433, 0591-2434, 0591-2451
Drug Label Context (from openFDA)
The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.
Boxed Warning
WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY Isotretinoin capsules can cause life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of isotretinoin capsules even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue isotretinoin capsules immediately and refer the patient to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ...
Indications & Usage
1 INDICATIONS AND USAGE Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period beca...
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Isotretinoin capsules are not substitutable with ABSORICA LD ® because of different bioavailability and recommended dosage. ( 2.1 , 5.3 ) Recommended dosage for isotretinoin capsules is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of isotretinoin capsules in divided doses. ( 2.1 ) Once daily dosing is not recommended. ( 2.1 ) If a dose of isotretinoin capsules is missed, just skip that dose. Do not take two d...
Contraindications
4 CONTRAINDICATIONS Pregnancy ( 4.1 , 8.1 ) Hypersensitivity to this product or any of its components ( 4.2 , 5.14 ) 4.1 Pregnancy Isotretinoin is contraindicated in pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . 4.2 Hypersensitivity Isotretinoin is contraindicated in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have ...
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions with isotretinoin or other isotretinoin capsule products are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] Psychiatric Disorders [see Warnings and Precautions ( 5.4 )] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.5 )] Serious Skin Reactions [see Warnings and Precautions ( 5.6 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] L...
Drug Interactions
7 DRUG INTERACTIONS Vitamin A : may cause additive adverse reactions ( 7.1 ) Tetracyclines : avoid concomitant use ( 7.2 ) 7.1 Vitamin A Isotretinoin is closely related to vitamin A. Therefore, the use of both vitamin A and isotretinoin at the same time may lead to vitamin A related adverse reactions. Patients treated with isotretinoin should be advised against taking supplements containing Vitamin A to avoid additive toxic effects. 7.2 Tetracyclines Concomitant treatment with isotretinoin an...
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Isotretinoin capsules, USP are supplied as follows: 10 mg capsules: White opaque/white opaque size 1 capsules imprinted with WPI and 2433 in black ink and filled with a yellow semi-solid and banded with a blue band. Box of 30 capsules (3 x 10 Prescription Packs): NDC 0591-2433-15 20 mg capsules: White opaque/light yellow opaque size 0 capsules imprinted with...
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