The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0777-2021·Announced 2021-09-08

Naproxen Sodium Tablets Recall Due to Manufacturing Quality Deviations

Granules USA, Inc. voluntarily recalled Naproxen Sodium Tablets USP 220 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects approximately 11.45 million tablets distributed in New York.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse effects. However, no reported illnesses or injuries are mentioned in the source text, and this is a voluntary, precautionary recall based on manufacturing deviations rather than documented product-related harm.

Plain-English summary

Granules USA, Inc. initiated a voluntary recall of Naproxen Sodium Tablets USP 220 mg (Caplet) in August 2021 due to Current Good Manufacturing Practice (CGMP) deviations. The affected product is manufactured by Granules India Limited and has NDC number 62207-762-36. Approximately 11.45 million tablets were involved in the recall, identified by batch code 7620060a.

The tablets were distributed in New York. The recall was initiated on August 11, 2021, following the firm's discovery of CGMP deviations in manufacturing. The FDA classified this as a Class II recall, meaning the condition could result in temporary or medically reversible adverse effects.

Consumers who have this product should discontinue use and consult their healthcare provider if they have any concerns about medication they may have taken. The recall was terminated on February 16, 2023.

The recalled product

Product
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36
Manufacturer
Granules USA, Inc.
Category
Drug — NSAID / Pain Reliever
Hazard
Affected units
11,450,000

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)

  • 7620060a

Distribution

Distributed in 1 state:

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