Preferred Pharmaceuticals Ranitidine Tablets Recall: FDA Class II

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

Product description

Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals

Lot numbers, UPCs & expiration codes

Lot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20

Where it was sold

CA, FL

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0617-2020
Classification: Class II
Status: Terminated
Recall initiated: Dec 2, 2019
FDA report date: Dec 18, 2019
Quantity: 316 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Preferred Pharmaceuticals, Inc

Original FDA data

Every field from FDA enforcement report D-0617-2020, exactly as published.

Show all FDA fields

City: Anaheim
State: CA
Status: Terminated
Country: United States
Event ID: 84422
Address: 1250 N Lakeview Ave Ste O
Code information: Lot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20
Postal code: 92807-1801
Report date: Dec 18, 2019
Product type: Drugs
Recall number: D-0617-2020
Classification: Class II
Recalling firm: Preferred Pharmaceuticals, Inc
Product quantity: 316 bottles
Termination date: May 9, 2023
Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Distribution pattern: CA, FL
Recall initiation date: Dec 2, 2019
Initial firm notification: E-Mail
Center classification date: Dec 9, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0617-2020, published Dec 18, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Preferred Pharmaceuticals Ranitidine Tablets Recall

Summary