The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0316-2020·Announced 2019-11-20

Apotex Recalls Equate Ranitidine Tablets Due to Possible NDMA Contamination

Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 1,132,453 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are listed in the source, the presence of a known carcinogenic impurity (NDMA) in a Class II drug recall aligns with the Severe tier for significant health risks.

Plain-English summary

Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer, 130 Tablets, distributed by Wal-Mart Stores, Inc. The recall involves 1,132,453 bottles of the product, which are available in both twin pack (NDC: 49035-100-07) and single pack (NDC: 49035-100-00) configurations. The product was distributed nationwide.

The recall was initiated due to Good Manufacturing Practice (GMP) deviations that resulted in possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall includes all lots of the product that remain within their expiration dates.

Consumers who have purchased these specific NDCs should stop using the product and return it to the place of purchase for a refund or contact Apotex Inc. for further instructions.

The recalled product

Product
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
Manufacturer
Apotex Inc.
Category
Drug — Prescription/OTC Medication
Hazard
Affected units
1,132,453

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Apotex Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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