Sun Pharmaceutical Recalls Subpotent Absorica LD Isotretinoin Capsules
Sun Pharmaceutical Industries is recalling Absorica LD (Isotretinoin) capsules because the active ingredient content was lower than the required specification limit.
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 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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug (lower than specification), which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a dangerous substance.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Absorica LD (Isotretinoin) Capsules 30 mg USP. The recall involves 47,520 prescription packs distributed nationwide in the USA. The specific lot affected is 17F28AA with an expiration date of 1/2020.
The recall was initiated because the isotretinoin content in the product was found to be lower than the specification limit during routine product monitoring. This condition is classified as a subpotent drug issue.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or point of distribution for a refund or replacement.
The recalled product
- Product
- ABSORICA LD (ISOTRETINOIN)
- Brand
- ABSORICA LD
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 47,520
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: 17F28AA
- Exp 1/2020
UPCs (1)
- 310631117313
Distribution
Distributed nationwide across the United States.
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