Pregabalin Capsules Recalled for Out-of-Specification Manufacturing Defects
Sun Pharmaceutical Industries is recalling Pregabalin 50 mg capsules due to out-of-specification results in particle size distribution and bulk density of the active pharmaceutical ingredient.
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: This is an FDA Class II recall involving manufacturing defects in active pharmaceutical ingredient specifications. No hospitalization or illness reports are stated in the source text, and the hazard is manufacturing-process related rather than known contamination or acute safety risk, placing it in the Moderate category.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Pregabalin Capsules, 50 mg, in bottles of 100 count (NDC 47335-687-88) nationwide in the USA due to failed tablet and capsule specifications. The active pharmaceutical ingredient did not meet specifications for particle size distribution and bulk density.
The affected product is lot number DNC0432A with expiration date 01/2023, manufactured by Sun Pharmaceutical Industries Ltd. in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey. A total of 696 bottles were distributed.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Patients should not stop taking their medication without consulting their healthcare provider, as doing so could result in a return of their condition.
The recalled product
- Product
- PREGABALIN (PREGABALIN)
- Brand
- PREGABALIN
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Medication
- Affected units
- 696
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 (2)
- Lot number: DNC0432A
- expiration 01/2023
UPCs (8)
- 0347335692884
- 0347335693881
- 0347335688887
- 0347335689884
- 0347335686883
- 0347335687880
- 0347335691887
- 0347335690880
Distribution
Distributed nationwide across the United States.
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