Medications & Supplements/Prescription Drugs

American Health Packaging: Ranitidine Tablets Recalled for Potential NDMA Impurity Above FDA Limits

Agency Publication Date: March 12, 2020

Summary

American Health Packaging is recalling 53,619 cartons of Ranitidine Tablets, USP (150 mg), a prescription medication used to treat stomach and intestinal ulcers. This recall was initiated due to the potential presence of N-Nitrosodimethylamine (NDMA) at levels higher than those established by the FDA. The affected products were distributed nationwide in unit dose blister cards and cartons with specific expiration dates through December 2020.

Risk

NDMA is classified as a probable human carcinogen. While no injuries have been reported, the presence of this impurity at elevated levels poses a potential long-term risk of cancer to consumers.

What You Should Do

Check your medication packaging for the product name Ranitidine Tablets, USP, 150 mg, distributed by American Health Packaging.
Look for NDC numbers 60687-322-01 (on the carton) or 60687-322-11 (on the unit dose card).
Verify if your medication belongs to the affected lot numbers: 179516 or 179745 (Exp 12/31/2019); 180712 (Exp 02/29/2020); 180819 (Exp 04/30/2020); 181403, 182544, 183155, or 183236 (Exp 05/31/2020); or 185739, 186600, or 186702 (Exp 12/31/2020).
Contact your healthcare provider or pharmacist for guidance on alternative treatments and to determine if you should stop taking the medication.
Return any unused product to the pharmacy where it was purchased for a refund.
Contact American Health Packaging at their Columbus, Ohio facility or via the contact information provided on their official website for further instructions.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Pharmaceutical refund through point of sale.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card)

Model:

NDC 60687-322-01

NDC 60687-322-11

D-1003-2020

Lot Numbers:

179516 (exp 12/31/2019)

179745 (exp 12/31/2019)

180712 (exp 02/29/2020)

180819 (exp 04/30/2020)

181403 (exp 05/31/2020)

182544 (exp 05/31/2020)

183155 (exp 05/31/2020)

183236 (exp 05/31/2020)

185739 (exp 12/31/2020)

186600 (exp 12/31/2020)

186702 (exp 12/31/2020)

Date Ranges: December 31, 2019 - December 31, 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85070

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies; Hospitals

Manufactured In: United States

Units Affected: 53,619 cartons

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

Check your medication packaging for the product name Ranitidine Tablets, USP, 150 mg, distributed by American Health Packaging.

Look for NDC numbers 60687-322-01 (on the carton) or 60687-322-11 (on the unit dose card).

Verify if your medication belongs to the affected lot numbers: 179516 or 179745 (Exp 12/31/2019); 180712 (Exp 02/29/2020); 180819 (Exp 04/30/2020); 181403, 182544, 183155, or 183236 (Exp 05/31/2020); or 185739, 186600, or 186702 (Exp 12/31/2020).

Contact your healthcare provider or pharmacist for guidance on alternative treatments and to determine if you should stop taking the medication.

Return any unused product to the pharmacy where it was purchased for a refund.

Contact American Health Packaging at their Columbus, Ohio facility or via the contact information provided on their official website for further instructions.

For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card)

Model:

NDC 60687-322-01

NDC 60687-322-11

D-1003-2020

Lot Numbers:

179516 (exp 12/31/2019)

179745 (exp 12/31/2019)

180712 (exp 02/29/2020)

180819 (exp 04/30/2020)

181403 (exp 05/31/2020)

182544 (exp 05/31/2020)

183155 (exp 05/31/2020)

183236 (exp 05/31/2020)

185739 (exp 12/31/2020)

186600 (exp 12/31/2020)

186702 (exp 12/31/2020)

Date Ranges: December 31, 2019 - December 31, 2020