Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity
Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves the presence of the NDMA impurity, a significant safety concern that meets the criteria for a Severe rating.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ranitidine Tablets, USP 75 mg, sold in 30-count and 80-count bottles under the Walgreens brand. The recall is due to the presence of the NDMA impurity detected in the product.
The affected products include NDC 0363-0131-30 (30-count bottles) and NDC 0363-0131-80 (80-count bottles). The recall covers all lots within the expiration date. The product was distributed to major distributors throughout the United States, who may have further distributed the product.
Consumers should stop using the recalled product and return it to the place of purchase for a refund. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
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)
- Batch Numbers: All lots within expiry.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Dr. Reddy's Laboratories, 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 18 products in this recall →Related recalls
Same manufacturer · Dr. Reddy's Laboratories, Inc.
See all →- ModerateVarenicline tablets recalled after an assay value fell below specification
FDA (Drugs) · 2025-12-17
- Moderate
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- SevereLevetiracetam Injection Label Mismatch Nationwide Recall
FDA (Drugs) · 2025-04-23
- ModerateFDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-12-18
Same hazard · ndma impurity
See all →- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets
FDA (Drugs) · 2021-05-26
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-02-10
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-01-20
- SevereDenton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SevereDirect Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
FDA (Drugs) · 2020-11-11