Agency classClass IIIOur severity:Low FDA (Drugs)·D-0009-2018·Announced 2017-10-18

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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

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: impurity
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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