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.
What this means for you
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
- cgmp-deviation
- manufacturing-quality
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:
- NY
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27