Medications & Supplements/Prescription Drugs

Teva Tretinoin Capsules Recalled for Failed Dissolution Tests

Agency Publication Date: February 2, 2022

Summary

Teva Pharmaceuticals USA has recalled approximately 1,175 bottles of Tretinoin Capsules (10 mg), a prescription medication used to treat certain medical conditions. The recall was issued because the capsules failed dissolution tests, meaning the drug may not release properly in the body as intended. No incidents or injuries have been reported to date regarding this issue.

Risk

If the medication does not dissolve properly, the patient may not receive the full dose of the drug, potentially making the treatment less effective for serious health conditions.

What You Should Do

This recall affects Tretinoin Capsules (10 mg) sold in 100-count bottles under the Teva Pharmaceuticals USA label (NDC 0555-0808-02).
Check your medication bottle to see if it matches lot number 100022970 with an expiration date of 08/2022.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tretinoin Capsules (100-count bottle)

Variants: 10 mg, Rx Only

Lot Numbers:

100022970 (Exp. 08/2022)

NDC:

0555-0808-02

Recall #: D-0520-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89385

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: pharmacies

Manufactured In: United States

Units Affected: 1,175 Bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Tretinoin Capsules (10 mg) sold in 100-count bottles under the Teva Pharmaceuticals USA label (NDC 0555-0808-02).

Check your medication bottle to see if it matches lot number 100022970 with an expiration date of 08/2022.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.