Dr. Reddy's Recalls Famotidine Tablets Due to Impurity Failure
Dr. Reddy's is recalling specific lots of famotidine tablets sold as CVS Pharmacy Acid Controller and Equate Famotidine due to an out-of-specification impurity result.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a failed impurity specification found during routine testing, with no reported illnesses or injuries.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 569,376 bottles of famotidine tablets, 10 mg, sold nationwide. The product is distributed as CVS Pharmacy Acid Controller (NDC 55111-118-30) and Equate Famotidine (NDC 49035-118-30). The recall is voluntary and classified as Class III by the FDA.
The recall was initiated because routine stability testing revealed an out-of-specification result for an individual related substance, specifically impurity 8, at the 24-month stability interval. The affected lots include specific expiration dates ranging from October 2017 to July 2018.
Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their pharmacist or Dr. Reddy's Laboratories for further instructions.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — OTC Drug
- Hazard
- Affected units
- 569,376
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 (20)
- Lot #: a) 79C408882B
- 79C408884C
- 79C408886B
- Exp 10/17
- 79C501523B
- Exp 01/18
- 79C501524B
- 79C502318B
- Exp 3/18
- b) 79C408885B
- 79C408886A
- 79C500967
- 79C501523C
- 79C501525A
- 79C501525B
- 79C501525C
- 79C501526B
- 79C502317A
- 79C504087B
- 79C504088A
Distribution
Distributed nationwide across the United States.
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